Linvatec Corporation
Largo, FL, US
Linvatec Corporation appears in FDA device records in Largo, FL. FDA records list 93 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 117 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
2 namesFDA records resolved to Linvatec Corporation carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Linvatec Corp DBA Linvatec/Halrecall
- Linvatec Corp. dba ConMed Linvatecenforcement report, recall
510(k) clearance history
Showing 50 of 93FDA records hold 93 510(k) clearances for Linvatec Corporation between 1992 and 2009. The busiest year on record is 1994, with 17. The most recent is 2009, with 5.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1992 | 1 |
| 1993 | 2 |
| 1994 | 17 |
| 1995 | 10 |
| 1996 | 9 |
| 1997 | 5 |
| 1998 | 7 |
| 1999 | 9 |
| 2000 | 2 |
| 2001 | 5 |
| 2002 | 4 |
| 2003 | 6 |
| 2004 | 4 |
| 2005 | 4 |
| 2006 | 3 |
| 2009 | 5 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K092998 | CONMED LINVATEC INTERCEPT IMPLANT | MBI | Substantially Equivalent | |
| K091549 | CONMED LINVATEC SOFT TISSUE TO BONE SYSTEM | MBI | Substantially Equivalent | |
| K090835 | CONMED LINVATEC BIO MINI-REVO SUTURE ANCHOR, MODEL C6170CR | MAI | Substantially Equivalent | |
| K090186 | CONMED LINVATEC PALADIN, PRELOADED WITH TWO #2 HI-FI SUTURES | MAI | Substantially Equivalent | |
| K083281 | EL LIGHTWAVE SUCTION ABLATOR, MODEL EL-2000-S, LIGHTWAVE SUCTION ABLATOR, MODEL IA-2000-S, LIGHTWAVE ABLATOR, MODEL IA- | GEI | Substantially Equivalent | |
| K060198 | MICROPOWER HAND PIECE : MEDIUM SPEED DRILL, SAGGITAL SAW, RECIPROCATING SAW, AND OSCILLATING SAW | HRX | Substantially Equivalent | |
| K060270 | MICROPOWER HAND PIECE: ORAL MAX HIGH SPEED DRILL | DZI | Substantially Equivalent | |
| K060260 | MICROPOWER HAND PIECE HIGH SPEED DRILL | HBC | Substantially Equivalent | |
| K050519 | ADVANCED TURBO DRIVE SYSTEM | GEY | Substantially Equivalent | |
| K050497 | BIOSCREW XTRALOK, 8X35MM & 8X40MM VIOLET | HWC | Substantially Equivalent | |
| K050227 | THREVO SUTURE ANCHOR WITH DISPOSABLE DRIVER | MBI | Substantially Equivalent | |
| K043106 | PINN-ACL CROSSPIN | HTY | Substantially Equivalent | |
| K042778 | BIOANCHOR WITH DISPOSABLE DRIVER, PRELOADED WITH ONE #2 HERCULINE SUTURE | HWC | Substantially Equivalent | |
| K041128 | SUTURE ARROW | MAI | Substantially Equivalent | |
| K041713 | SUPER REVO HERCULINE SUTURE ANCHOR | MBI | Substantially Equivalent | |
| K033573 | LINVATEC 10K IRRIGATION SYSTEM | HRX | Substantially Equivalent | |
| K033804 | BIOANCHOR WITH DISPOSABLE DRIVER | HWC | Substantially Equivalent | |
| K033748 | TRIDENT RESECTION ABLATOR | GEI | Substantially Equivalent | |
| K032607 | POWERPRO PNEUMATIC SYSTEM, MODELS PRO6150, PRO6175, PRO6185 | DZI | Substantially Equivalent | |
| K031994 | LINVATEC 300W XENON LIGHT SOURCE | GCT | Substantially Equivalent | |
| K031098 | 3-CCD DIGITAL CAMERA SYSTEM | GCJ | Substantially Equivalent | |
| K030720 | ULTRABLATOR ELECTRODE | GEI | Substantially Equivalent | |
| K022827 | ULTRAFIX KNOTLESS MINIMITE SUTURE ANCHOR | MBI | Substantially Equivalent | |
| K013131 | BIOSCREW XTRALOK | HWC | Substantially Equivalent | |
| K020377 | PRE-LOADED BIOSTINGER HORNET | HWC | Substantially Equivalent | |
| K013369 | RESECTION ABLATOR | GEI | Substantially Equivalent | |
| K013553 | PRE-LOADED ULTRAFIX RC | MBI | Substantially Equivalent | |
| K013117 | RESECTION ABLATOR | HRX | Substantially Equivalent | |
| K012320 | POWERPRO BATTERY SYSTEM | HAB | Substantially Equivalent | |
| K003984 | SUPER REVO SUTURE ANCHOR | MAI | Substantially Equivalent | |
| K002088 | SHAVER ABLATOR | HRX | Substantially Equivalent | |
| K002523 | ADVANTAGE DRIVE SYSTEM | HBC | Substantially Equivalent | |
| K993885 | ULTRABLATOR ELECTRODE | JOS | Substantially Equivalent | |
| K993339 | ENDOPEARL WITH THREADER | MAI | Substantially Equivalent | |
| K991024 | BONE BULLET SUTURE ANCHOR | HWC | Substantially Equivalent | |
| K990194 | BIOBUTTON | HWC | Substantially Equivalent | |
| K991830 | CAPSULAR SHRINKAGE ELECTRODE | JOS | Substantially Equivalent | |
| K991715 | BIOSTINGER-V BIOABSORBABLE MENISCAL REPAIR DEVICE | MAI | Substantially Equivalent | |
| K990770 | BIORC ANCHOR | HWC | Substantially Equivalent | |
| K990524 | E9000 SYSTEM | HRX | Substantially Equivalent | |
| K984171 | ENDOPEARL | MAI | Substantially Equivalent | |
| K983652 | ABLATOR ELECTRODE | HRX | Substantially Equivalent | |
| K983186 | BIO-ANCHOR, PRE-LOADED BIOABSORBABLE SUTURE ANCHOR | MAI | Substantially Equivalent | |
| K981636 | INTEGRATED DRIVE/PUMP SYSTEM | HRX | Substantially Equivalent | |
| K981692 | MENISCAL REPAIR DEVICE | MBI | Substantially Equivalent | |
| K981637 | INTEGRATED DRIVE/PUMP SYSTEM FOR OTOLARYNGOLOGY | ERL | Substantially Equivalent | |
| K981269 | UNIVERSAL DRIVE SYSTEM | HRX | Substantially Equivalent | |
| K974538 | MENISCAL REPAIR DEVICE | HWC | Substantially Equivalent | |
| K973758 | BIOSCREW ABSORBABLE INTERFERENCE SREW | HWC | Substantially Equivalent | |
| K963932 | PRELOADED SOFT TISSUE ANCHOR | MBI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1017294 | 1017294 | Linvatec Corporation | 11311 Concept Boulevard, LARGO, FL 33773 US | 2026 | and 79 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- FEMAccessories, Photographic, For Endoscope (Exclude Light Sources)
- FYDApparatus, Exhaust, Surgical
- GCXApparatus, Suction, Operating-Room, Wall Vacuum Powered
- HSTApparatus, Traction, Non-Powered
- HRXArthroscope
- GFGBit, Surgical
- GFABlade, Saw, General & Plastic Surgery, Surgical
- EQJBur, Ear, Nose And Throat
- GFFBur, Surgical, General & Plastic Surgery
- FXMCamera, Still, Endoscopic
- HMXCannula, Ophthalmic
- GEACannula, Surgical, General & Plastic Surgery
- GBXCatheter, Irrigation
- GDJClamp, Surgical, General & Plastic Surgery
- DZIDrill, Bone, Powered
- ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- FETEndoscopic Video Imaging System/Component, Gastroenterology-Urology
- GCLEsophagoscope, General & Plastic Surgery
- GENForceps, General & Plastic Surgery
- HTJGauge, Depth
- GDFGuide, Needle, Surgical
- FZXGuide, Surgical, Instrument
- FZYHammer, Surgical
- FXRHolder, Camera, Surgical
- HIHHysteroscope (And Accessories)
- HSZInstrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment
- HIGInsufflator, Hysteroscopic
- HIFInsufflator, Laparoscopic
- GCJLaparoscope, General & Plastic Surgery
- HETLaparoscope, Gynecologic (And Accessories)
- GCTLight Source, Endoscope, Xenon Arc
- FCWLight Source, Fiberoptic, Routine
- FSYLight, Surgical, Ceiling Mounted
- FSTLight, Surgical, Fiberoptic
- GYBMedia, Electroconductive
- FTLMesh, Surgical, Polymeric
- HBCMotor, Drill, Electric
- HBBMotor, Drill, Pneumatic
- GEYMotor, Surgical Instrument, Ac-Powered
- GETMotor, Surgical Instrument, Pneumatic Powered
- GABNeedle, Suturing, Disposable
- HAWNeurological Stereotaxic Instrument
- FWZOperating Room Accessories Table Tray
- FHOPneumoperitoneum Needle
- CANRegulator, Pressure, Gas Cylinder
- HABSaw, Powered, And Accessories
- GAESnare, Surgical
- EQHSource, Carrier, Fiberoptic Light
- GDWStaple, Implantable
- GAPSuture, Nonabsorbable, Silk
- GARSuture, Nonabsorbable, Synthetic, Polyamide
- GASSuture, Nonabsorbable, Synthetic, Polyester
- GATSuture, Nonabsorbable, Synthetic, Polyethylene
- GAWSuture, Nonabsorbable, Synthetic, Polypropylene
- FMFSyringe, Piston
- FSMTray, Surgical, Instrument
- GAZTubing, Noninvasive
- BYXTubing, Pressure And Accessories
- FRGWrap, Sterilization
Recall records
Showing 25 of 117| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1681-2013 | ***REF C7122***QTY 1***APEX Arthroscopy Tubing Set. Intended for use for joint irrigation and dissention during arthroscopic procedures. | Conmed Linvatec received complaints that their products C7120 APEX Arthroscopy Tubing Set, One Connection and C7122 APEX Arthroscopy Tubing Set, Two Connection, contained a scratch/grooved area on the inside diameter of the pressure fitting that may cause the APEX Irrigation (pump) Console to sense a pressure drop and increase fluid flow to the surgical site. | Class II | Terminated | |
| Z-1680-2013 | ***REF C7120***APEX Arthroscopy Tubing Set. Intended for use for joint irrigation and dissention during arthroscopic procedures. | Conmed Linvatec received complaints that their products C7120 APEX Arthroscopy Tubing Set, One Connection and C7122 APEX Arthroscopy Tubing Set, Two Connection, contained a scratch/grooved area on the inside diameter of the pressure fitting that may cause the APEX Irrigation (pump) Console to sense a pressure drop and increase fluid flow to the surgical site. | Class II | Terminated | |
| Z-1340-2013 | Ref: VP1600 HD Still Capture System ConMed Linvatec . Captures, stores and transfers images generated by a medical endoscopic camera system during surgical procedures. | The VP1600 HD Still Capture Image System is recalled due to an anomaly between the software code in the VP1600 console and the communications interface for various keyboard key strokes (Caps lock and Num Lock) which may lock up and requires the user to reboot to continue. | Class II | Terminated | |
| Z-1619-2013 | GENESYS Cross FT Suture Anchor with Two #2 (5 metric) Hi-FI Registered Trade Mark Sutures Rx Only STERILE EO CONMED LINVATEC REF CFBC-4502. Reattachment of soft tissue to bone in orthopedic surgical procedures | Incorrect blue/white suture was used. | Class II | Terminated | |
| Z-0917-2013 | D3000I Advantage Drive System, 230v, surgical instrument motor. Product Usage: The Advantage Drive Systems function as a powered instrument system consisting of handpieces and accessories to perform cutting of soft tissue and bone | The Membrane Switch Panel (referred to as "front panel" of the component part number A34-003-207, used on both the D3000 and D3000I Advantage Drive System, contained the incorrect symbology per third edition IEC60606-01 Medical Electrical Equipment: General requirements for basic safety and essential performance. | Class III | Terminated | |
| Z-0916-2013 | D3000 Advantage Drive System, 115v Product Usage: The Advantage Drive Systems function as a powered instrument system consisting of handpieces and accessories to perform cutting of soft tissue and bone | The Membrane Switch Panel (referred to as "front panel" of the component part number A34-003-207, used on both the D3000 and D3000I Advantage Drive System, contained the incorrect symbology per third edition IEC60606-01 Medical Electrical Equipment: General requirements for basic safety and essential performance. | Class III | Terminated | |
| Z-0789-2013 | ConMed Linvatec Biomaterials, PopLok bone Punch PKL-35M, 3.5mm Orthopedic manual surgical instrument - Bone Punch | ConMed Linvatech recalled one lot of their PopLok bone Punch 3.5mm because the metal shaft diameter is 4.5mm when it should be 3.5mm. | Class II | Terminated | |
| Z-2151-2012 | PopLok Punch labeled in part: "PKL-35M***3.5mm***QTY 1***PopLok Punch***ConMed Linvatec Biomaterials, Ltd. Hermiankatu 6-8L 33720 Tampere, FINLAND***Rx Only***ConMed Linvatec 11311 Concept Blvd Largo, FL 33773-4908 USA***Made in USA***" Intended Use: Bone Punch. | ConMed Linvatec recalled one lot of their PopLok bone Punch 3.5MM because the metal shaft diameter is 4.5mm when it should have been 3.5mm. | Class II | Terminated | |
| Z-0068-2013 | NP211H***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA*** To reattach soft tissue to bone in orthopedic surgical procedures | Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling PressFT HI-FI Sutures (items NP211, NP212, NP261, NP262, NP211H, NP261H-all lot numbers) due to the potential for the distal tip of the driver to become separated from the driver shaft after successful insertion of the implant. | Class II | Terminated | |
| Z-0067-2013 | "***PressFT***2.1 w/ One #2 (5 metric) Hi-Fi***Suture***NP211***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA*** To reattach soft tissue to bone in orthopedic surgical procedures | Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling PressFT HI-FI Sutures (items NP211, NP212, NP261, NP262, NP211H, NP261H-all lot numbers) due to the potential for the distal tip of the driver to become separated from the driver shaft after successful insertion of the implant. | Class II | Terminated | |
| Z-0066-2013 | "***PressFT***2.1 w/ Two #0 (3.5 metric) Hi-Fi***Sutures***NP212***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA*** To reattach soft tissue to bone in orthopedic surgical procedures | Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling PressFT HI-FI Sutures (items NP211, NP212, NP261, NP262, NP211H, NP261H-all lot numbers) due to the potential for the distal tip of the driver to become separated from the driver shaft after successful insertion of the implant. | Class II | Terminated | |
| Z-0065-2013 | "***Press FT***2.6 w/ One #2 (5 metric) Hi-Fi***Suture, HIP***N2***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA*** To reattach soft tissue to bone in orthopedic surgical procedures | Linvatec Corporation DBA ConMed Linvatec in Largo, FL is recalling Press FT HI-FI Sutures (items NP 211, NP 212, NP 261, NP 262, NP211H, NP261H-all lot numbers) due to the potential for the distal tip of the driver to become separated from the driver shaft after successful insertion of the implant. | Class II | Terminated | |
| Z-0064-2013 | "***PressFT***2.6 w/ One #2 (5 metric) Hi-Fi***Suture***NP261***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA*** To reattach soft tissue to bone in orthopedic surgical procedures | Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling PressFT HI-FI Sutures (items NP211, NP212, NP261, NP262, NP211H, NP261H-all lot numbers) due to the potential for the distal tip of the driver to become separated from the driver shaft after successful insertion of the implant. | Class II | Terminated | |
| Z-0063-2013 | "***PressFT***2.6 w/ Two #1 (4 metric) Hi-Fi***Sutures***NP262***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA*** To reattach soft tissue to bone in orthopedic surgical procedures | Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling PressFT HI-FI Sutures (items NP211, NP212, NP261, NP262, NP211H, NP261H-all lot numbers) due to the potential for the distal tip of the driver to become separated from the driver shaft after successful insertion of the implant. | Class II | Terminated | |
| Z-0384-2013 | "***SENTINEL***Cannulated Drill Bit***S8585***8.5 X 229mm (9")***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***LOT***2009-02***". This drill bit is an eccentric mono-fluted cutting edge for drilling bone tunnels in ACL and PCL reconstruction. | Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling the S8580, 8.0MM SENTINEL Cannulated Drill Bit, lot numbers 322225 and 322226; and the S8585, 8.5MM SENTINEL Cannulated Drill Bit, lot number 322287. Recall was initiated due to the incorrect labeling on package. | Class II | Terminated | |
| Z-0383-2013 | "***SENTINEL***Cannulated Drill Bit***S8580***8 X 229mm (9")***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***LOT***2012-03***". This drill bit is an eccentric mono-fluted cutting edge for drilling bone tunnels in ACL and PCL reconstruction. | Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling the S8580, 8.0MM SENTINEL Cannulated Drill Bit, lot numbers 322225 and 322226; and the S8585, 8.5MM SENTINEL Cannulated Drill Bit, lot number 322287. Recall was initiated due to the incorrect labeling on package. | Class II | Terminated | |
| Z-0164-2013 | "***All in one CrossFT***Punch***PFT-00M***4.5mm to 6.5mm***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***" To create pathway for insertion of CrossFT Suture Anchor into bone. | ConMed Linvatec is recalling the product due to the punch being mis-assembled with the incorrect handled. The correct handle is a clear anodized silver colored handle. | Class II | Terminated | |
| Z-2147-2012 | CrossFT Punch, Product Number PFT-45M. Manufacturer: CONMED LINVATEC. The intended use is to create a hole to facilitate insertion of the CrossFT suture anchor into bone. | ConMed Linvatec recalled lot number #156920, PFT-45M, CrossFT Punch because there is a possibility that the device was etched incorrectly listing the item number as PFT-00M and includes incorrect depth lines for insertion. | Class II | Terminated | |
| Z-2469-2012 | Catheter Irrigation Set labeled in part: ***24K Arthroscopy Outflow/Suction Tubing Set*** This Arthroscopy Tubing Set is intended for use, in conjunction with the ConMed Linvatec 24k Pump, for pump-induced outflow and/or suction of fluid from the joint during arthroscopic procedures. | ConMed Linvatec recalled their 24k Arthroscopy Outflow/Suction Tubing Set (Product Number 24k100)because there is a possibility that the product may have a breach in the Tyvek seal that could potentially compromise the sterility of the contents. | Class II | Terminated | |
| Z-2456-2012 | ***REF LS7700***Qty 1*** EC REP*** ConMed Linvatec Xenon Universal Light Source | Linvatec Corporation dba ConMed Linvatec, Largo, FL initiated a recall of their products LS7700 Xenon Universal Light Source and LS7600 Xenon Light Source are intended to be used with an endoscope to provide illumination during endoscopic procedures. | Class II | Terminated | |
| Z-2455-2012 | ***REF LS7600***Qty 1*** EC REP*** ConMed Linvatec Xenon Light Source | Linvatec Corporation dba ConMed Linvatec, Largo, FL initiated a recall of their products LS7700 Xenon Universal Light Source and LS7600 Xenon Light Source are intended to be used with an endoscope to provide illumination during endoscopic procedures. | Class II | Terminated | |
| Z-2703-2011 | "***LINVATEC SRS SHOULDER RESTORATION SYSTEM CrossFT 5.5mm CrossFT Suture Anchor with Two#2 (5 metric) Hi-Fi Sutures***SRS.Linvatec.com***ConMed Linvatec Biomaterials, Ltd. Hemiankatu 6-8L 33720 Tampere, FINLAND***STERILE EO***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA Made in USA***REF CFP-5502***" The non absorbable suture anchor is intended to reattach soft tissue to bone in orthopedic surgical procedures. | ConMed Linvatec, Largo, FL is recalling CrossFT Suture Anchor with Two #2 HI-Fi sutures, Lot 211581, Product Number CFP-5502. There is a possibility that the product may have been incorrectly assembled. The disposable driver may have the incorrect color handle (red versus black). | Terminated | ||
| Z-1880-2011 | POUCH/CARTON LABEL: ***REF 5023-138***9.5 x 25.5 x 0.4mm***QTY 1***MICRO SAGITTAL BLADE, FINE***STERILE***Rx Only***CONMED LINVATEC, CONMED LINVATEC 11211 CONCEPT BLVD LARGO, FL 33773-4908 USA***Made in USA*** To cut soft tissue or bone | On Nov 30, 2010 ConMed Linvatec, Largo, FL recalled their Micro Sagittal Blade, Fine Lot number 180209, Product Number 5023-138. Some units of Micro Sagittal Blade, Fine from Lot 180209 may have compromised seals in the sterile packaging. | Terminated | ||
| Z-1893-2011 | ***REF VP6528***Qty 1***Articulating Arm, Secondary Flat Panel***RX Only***See Instructions for Use***CONMED LINVATEC, CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA*** Catalog No Product VPN6528 Articulating Arm, Secondary Flat Panel. 690-0024-00 Arm, Wall Mount, Flat Screen, GCX For mounting and positioning of flat screen monitors. | If the VHM Arm is left in the locked position, the gas spring can lose pressure and releasing the lock can result in a sudden downward movement. | Terminated | ||
| Z-1821-2011 | ***REF 24k100***QTY 1***24k Arthroscopy Outflow/Suction Tubing Set***MADE IN USA***Rx Only***CONMED LINVATEC, CONMED LINVATEC 11311 CONCEPT BLVD, LARGO, GL 33773-4900*** For use in conjunction with the ConMed Linvatec 24k Pump, for pump-induced outflow and/or suction of fluid from the joint during arthroscopic procedures. | On 09/13/2010 ConMed Linvatec, Largo, FL initiated a recall on 24k100 Arthroscopy Outflow/Suction Tube Set used with the ConMed Linvatec 24k Pump. The 24k100 Arthroscopy Outflow/Suction Tubing Set Lots 22747-000, 22748-000, and 2749-000 may have been incorrectly assembled and could potentially allow waste to enter the sterile field. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain