Warsaw Orthopedic, Inc.
Warsaw, IN, US
WARSAW ORTHOPEDIC, INC. appears in FDA device records in Warsaw, IN. FDA records list 24 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 16 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Warsaw Orthopedic, Inc. 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.
- Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEKrecall
510(k) clearance history
FDA records hold 24 510(k) clearances for Warsaw Orthopedic, Inc. between 1983 and 1989. The busiest year on record is 1987, with 9. The most recent is 1989, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1983 | 1 |
| 1984 | 1 |
| 1985 | 3 |
| 1986 | 3 |
| 1987 | 9 |
| 1988 | 4 |
| 1989 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K892877 | CRADLE, HOSPITAL BED CLOTHING | FNJ | Substantially Equivalent | |
| K883784 | TSRH ANTERIOR SPINAL SCREWS, STAPLES AND END PLATE | LYQ | Substantially Equivalent for Some Indications | |
| K883783 | TSRH SACRAL SPINAL SCREW | KWP | Substantially Equivalent for Some Indications | |
| K880212 | TSRH H/M HOOK HOLDER W/ROD MOVER | KWP | Substantially Equivalent | |
| K880211 | TSRH H/M HOOK HOLDER | KWP | Substantially Equivalent | |
| K880215 | TSRH H/M HOOK, EYEBOLT/LOCK NUT ASSEM., SPINAL ROD | KWP | Substantially Equivalent | |
| K880214 | TSRH H/M TORQUE LIMITING WRENCH | KWP | Substantially Equivalent | |
| K870843 | SCHULTZ PHALANGEAL COMP TRIAL/METACARPAL COMP TRIA | HWT | Substantially Equivalent | |
| K870842 | SCHULTZ PHALANGEAL COMP RASP/METACARPAL COMP RASP | HTP | Substantially Equivalent | |
| K870830 | WARSAW ORTHOPEDIC TSR CROSS LINK SYSTEM | KWP | Substantially Equivalent | |
| K870848 | SCHULTZ METACARPAL COMPONENT DRIVER | HWR | Substantially Equivalent | |
| K870847 | SCHULTZ PHALANGEAL COMPONENT DRIVER | HWR | Substantially Equivalent | |
| K870846 | SCHULTZ MP COMPONENT PUNCH | HWP | Substantially Equivalent | |
| K870844 | SCHULTZ PROSTHESIS COMPONENT INSERTER EXTRACTOR | HWB | Substantially Equivalent | |
| K870845 | WARSAW ORTHOPEDIC POINTED REAMER | HTO | Substantially Equivalent | |
| K870727 | WARSAW ORTHOPEDIC I BONE PLATE | KTW | Substantially Equivalent | |
| K862311 | SCREW DRIVER/BONE SCREW WRENCH/TAP & GUIDE PIN | KTT | Substantially Equivalent | |
| K862254 | WARSAW ORTHOPEDIC BONE PLATE | HRS | Substantially Equivalent | |
| K860074 | SCHULTZ METACARPOPHALANGEAL JOINT PROSTHESIS | Substantially Equivalent | ||
| K851919 | SUPRACONDYLAR BONE PLATE | KTT | Substantially Equivalent | |
| K852026 | FEMORAL PROXIMAL DIAGNOSAL SCREW, FEMORAL TRANSVER | HWC | Substantially Equivalent | |
| K852020 | INTERLOCKING FEMORAL NAIL(LEFT & RIGHT) TIBIAL NAI | HSB | Substantially Equivalent | |
| K842293 | PARTIALLY THREADED BONE FIX. PIN | JDW | Substantially Equivalent | |
| K832884 | FIXATION STAPLE DRIVER/EXTRACTOR | JDR | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1824199 | 1824199 | WARSAW ORTHOPEDIC, INC. | 2500 SILVEUS CROSSING, WARSAW, IN 46582 US | 2026 | and 75 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- HRXArthroscope
- HWJAwl
- FNJBed, Manual
- HXWBender
- HTWBit, Drill
- EQJBur, Ear, Nose And Throat
- JDQCerclage, Fixation
- HXDClamp
- HXQCrimper, Pin
- HXZCutter, Wire
- GDIDissector, Surgical, General & Plastic Surgery
- HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)
- HWRDriver, Prosthesis
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- HTEElevator
- HWBExtractor
- HTPFile
- HTDForceps
- HTJGauge, Depth
- GDHGouge, Surgical, General & Plastic Surgery
- GDFGuide, Needle, Surgical
- FZXGuide, Surgical, Instrument
- GDGHook, Surgical, General & Plastic Surgery
- HWAImpactor
- DZEImplant, Endosseous, Root-Form
- JDNImplant, Fixation Device, Spinal
- HXPInstrument, Bending Or Contouring
- HWNInstrument, Compression
- HTZInstrument, Cutting, Orthopedic
- HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
- HTSKnife, Orthopedic
- FSZLight, Surgical, Carrier
- HXLMallet
- EZXMesh, Surgical, Metal
- GEYMotor, Surgical Instrument, Ac-Powered
- HWMOsteotome
- JDWPin, Fixation, Threaded
- JEYPlate, Bone
- HRSPlate, Fixation, Bone
- HTCPliers, Surgical
- HXBProbe
- JDKProsthesis, Hip, Cement Restrictor
- JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- HWPPunch, Femoral Neck
- HTOReamer
- GADRetractor
- HSBRod, Fixation, Intramedullary And Accessories
- HRRScissors, Orthopedic, Surgical
- HWCScrew, Fixation, Bone
- HXXScrewdriver
- JDRStaple, Fixation, Bone
- GWFStimulator, Electrical, Evoked Response
- ETNStimulator, Nerve
- HXGTamp
- HWXTap, Bone
- FTYTape, Measuring, Rulers And Calipers
- HWTTemplate
- FSMTray, Surgical, Instrument
- HWKTrephine
- HXCWrench
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1017-2009 | Medtronic TSRH Spinal System, 3Dx Splined Connector, Large; Medtronic Sofamor Danek, Memphis, TN; REF 8351512. The device is intended for orthosis, spinal pedicle fixation for degenerative disc disease. The product is used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients; posterior non-cervical, non-pedicle screw fixation or for anterior use for certain conditions. | The thickness of the connector may be under specification, which could cause the implant to break during surgery or after implantation. | Terminated | ||
| Z-1016-2009 | Medtronic TSRH Spinal System, 3Dx Splined Connector, Medium; Medtronic Sofamor Danek, Memphis, TN; REF 8351511. The device is intended for orthosis, spinal pedicle fixation for degenerative disc disease. The product is used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients; posterior non-cervical, non-pedicle screw fixation or for anterior use for certain conditions. | The thickness of the connector may be under specification, which could cause the implant to break during surgery or after implantation. | Terminated | ||
| Z-1015-2009 | Medtronic TSRH Spinal System, 3Dx Splined Connector, Small; Medtronic Sofamor Danek, Memphis, TN; REF 8351510. The device is intended for orthosis, spinal pedicle fixation for degenerative disc disease. The product is used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients; posterior non-cervical, non-pedicle screw fixation or for anterior use for certain conditions. | The thickness of the connector may be under specification, which could cause the implant to break during surgery or after implantation. | Terminated | ||
| Z-1014-2009 | Medtronic TSRH 3DX Implant Set; SPS002058. Sets are unlabeled, but contain individually labeled 3Dx Splined Connectors in sizes small, medium and large. The device is intended for orthosis, spinal pedicle fixation for degenerative disc disease. The product is used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients; posterior non-cervical, non-pedicle screw fixation or for anterior use for certain conditions. | The thickness of the connector may be under specification, which could cause the implant to break during surgery or after implantation. | Terminated | ||
| Z-0125-2008 | Medtronic Sofamor Danek COLORADO 2" SPINAL SYSTEM Break-Off Nut, non-sterile, RX; Catalog Number 8634111, Medtronic, Memphis, TN 38138. | Assembly may be compromised: Two thread grooves are missing on the nut, which may cause damage to the bone screw and result in the need for the bone screw to be replaced. | Terminated | ||
| Z-0114-2008 | Medtronic Sofamor Danek METRx (TM) System Bayonet Electrosurgical Pencil, sterile, Manufactured at Warsaw, Indiana; REF (P/N) 9560575. | Packaging weakness may compromise sterility and instructions for use are inadequate. | Terminated | ||
| Z-0993-05 | Medtronic Sofamor Danek brand METRx System MD Procedure Kit; Ref 9560030. | The package is labeled as sterile, but there may be a hole in the immediate package caused by the carton design. | Terminated | ||
| Z-0992-05 | Medtronic Sofamor Danek brand METRx System 18 mm Med Procedure Kit; Ref 9560018. | The package is labeled as sterile, but there may be a hole in the immediate package caused by the carton design. | Terminated | ||
| Z-0991-05 | Medtronic Sofamor Danek brand METRx System 16 mm Med Procedure Kit; Ref 9560016. | The package is labeled as sterile, but there may be a hole in the immediate package caused by the carton design. | Terminated | ||
| Z-1090-05 | Medtronic Sofamor Danek brand LT CAGE lumbar tapered fusion device implant 14 mm x 17.5 mm x 23 mm; Catalog number 8941423. | The product is labeled as sterile, but this lot was not sterilized. | Terminated | ||
| Z-0451-05 | ATLANTIS Element Express Kit; a sterile kit for cervical spine surgery which includes hex-head screwdriver, bone plate and 4 bone screws; catalog number 786-145. | The hex head of the screw driver may be too large to fit the screw heads of the bone screws included in the kit. | Terminated | ||
| Z-0450-05 | ATLANTIS Element Express Kit; a sterile kit for cervical spine surgery which includes hex-head screwdriver, bone plate and 4 bone screws; catalog number 786-142. | The hex head of the screw driver may be too large to fit the screw heads of the bone screws included in the kit. | Terminated | ||
| Z-0449-05 | ATLANTIS Element Express Kit; a sterile kit for cervical spine surgery which includes hex-head screwdriver, bone plate and 4 bone screws; catalog number 786-140. | The hex head of the screw driver may be too large to fit the screw heads of the bone screws included in the kit. | Terminated | ||
| Z-0448-05 | ATLANTIS Element Express Kit; a sterile kit for cervical spine surgery which includes hex-head screwdriver, bone plate and 4 bone screws; catalog number 786-127. | The hex head of the screw driver may be too large to fit the screw heads iof the bone screws included in the kit. | Terminated | ||
| Z-0447-05 | ATLANTIS Element Express Kit; a sterile kit for cervical spine surgery which includes hex-head screwdriver, bone plate and 4 bone screws; catalog number 786-125. | The hex head of the screw driver may be too large to fit the screw heads of the bone screws included in the kit. | Terminated | ||
| Z-0446-05 | ATLANTIS Element Express Kit; a sterile kit for cervical spine surgery which includes hex-head screwdriver, bone plate and 4 bone screws; catalog number 786-123. | The hex head of the screw driver may be too large to fit the screw heads of the bone screws included in the kit. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain