Wrightmedicaltechnologyinc
Arlington, TN, US
Wrightmedicaltechnologyinc appears in FDA device records in Arlington, TN. FDA records list 302 510(k) clearances between and , 9 PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 302
- PMA records
- 9
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 302FDA records hold 302 510(k) clearances for Wrightmedicaltechnologyinc between 1993 and 2023. The busiest year on record is 1997, with 19. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1993 | 1 |
| 1994 | 9 |
| 1995 | 18 |
| 1996 | 14 |
| 1997 | 19 |
| 1998 | 4 |
| 1999 | 5 |
| 2000 | 5 |
| 2001 | 6 |
| 2002 | 7 |
| 2003 | 7 |
| 2004 | 16 |
| 2005 | 14 |
| 2006 | 17 |
| 2007 | 7 |
| 2008 | 12 |
| 2009 | 10 |
| 2010 | 16 |
| 2011 | 17 |
| 2012 | 12 |
| 2013 | 15 |
| 2014 | 19 |
| 2015 | 15 |
| 2016 | 3 |
| 2017 | 12 |
| 2018 | 7 |
| 2019 | 8 |
| 2020 | 2 |
| 2021 | 3 |
| 2022 | 1 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K222835 | Prophecy Preoperative Navigation Alignment System | HSN | Substantially Equivalent | |
| K213342 | PRO-DENSE LoVisc Bone Graft Substitute | MQV | Substantially Equivalent | |
| K212996 | Sterile PHALINX Hammertoe System | HWC | Substantially Equivalent | |
| K202815 | PROPHECY Preoperative Navigation Alignment System | HSN | Substantially Equivalent | |
| K201259 | ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating System | HRS | Substantially Equivalent | |
| K200507 | PRO-DENSE LoVisc Bone Graft Substitute | MQV | Substantially Equivalent | |
| K193067 | The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total Ankle Revision System | HSN | Substantially Equivalent | |
| K191393 | INFINITY Total Ankle System, INBONE Total Ankle System | HSN | Substantially Equivalent | |
| K190970 | PROSTEP™ TBI™ (Tailors Bunion Implant) System | HWC | Substantially Equivalent | |
| K183620 | PROSTEP TBC Implant System | HRS | Substantially Equivalent | |
| K190482 | IGNITE Bone Void Filler | MQV | Substantially Equivalent | |
| K190670 | ORTHOLOC™ 2 Lapidus with Rotation System | HRS | Substantially Equivalent | |
| K190283 | PROSTIM Injectable Inductive Graft | MQV | Substantially Equivalent | |
| K183026 | Wright Jones Fracture System | HWC | Substantially Equivalent | |
| K181377 | PROSTEP MICA Screw System | HWC | Substantially Equivalent | |
| K182823 | PRODENSE Bone Graft Substitute | MQV | Substantially Equivalent | |
| K181255 | PRODENSE Bone Graft Substitute | MQV | Substantially Equivalent | |
| K181557 | INFINITY Total Ankle System | HSN | Substantially Equivalent | |
| K180730 | INVISION Total Ankle Revision System | HSN | Substantially Equivalent | |
| K180024 | SALVATION Midfoot Nail | HWC | Substantially Equivalent | |
| K180832 | SALVATION External Fixation System | KTT | Substantially Equivalent | |
| K172633 | INFINITY Total Ankle System | HSN | Substantially Equivalent | |
| K171852 | DARCO Locking Bone Plate System | HRS | Substantially Equivalent | |
| K171067 | INVISION Total Ankle Revision System | HSN | Substantially Equivalent | |
| K170642 | GRAVITY™ Soft Tissue Repair System | GAT | Substantially Equivalent | |
| K170968 | PROPHECY INVISION Pre-operative Navigation System | HSN | Substantially Equivalent | |
| K170249 | GRAVITY™ Syndesmosis LP | HTN | Substantially Equivalent | |
| K170889 | HV Screw System | HWC | Substantially Equivalent | |
| K163650 | ORTHOLOC® 3Di Ankle Fusion Plating System Line Extension | HRS | Substantially Equivalent | |
| K162353 | MICATM Screw System | HWC | Substantially Equivalent | |
| K163039 | ORTHOLOC® 3Di Small Bones Plating | HRS | Substantially Equivalent | |
| K170265 | GRAVITYTM PEEK-OPTIMA Suture Anchor | MBI | Substantially Equivalent | |
| K162795 | PROPHECY INVISION Preoperative Navigation Alignment System | HSN | Substantially Equivalent | |
| K163044 | ORTHOLOC® 3Di Ankle Fracture Plating System | HRS | Substantially Equivalent | |
| K152062 | BIOFOAM Bone Wedge | HRS | Substantially Equivalent | |
| K153008 | INVISION Total Ankle Revision System | HSN | Substantially Equivalent | |
| K153635 | SALVATION(R) External Fixation System | KTT | Substantially Equivalent | |
| K152974 | ORTHOLOC® 3Di Foot Plating Reconstruction System | HRS | Substantially Equivalent | |
| K150640 | RX-FIX Mini Rail External Fixator | KTT | Substantially Equivalent | |
| K151838 | PRO-TOE Hammertoe Fixation System | HWC | Substantially Equivalent | |
| K151442 | TOTAL COMPRESSION PLATING (TCP) SYSTEM | HRS | Substantially Equivalent | |
| K152045 | SALVATION® External Fixation System | KTT | Substantially Equivalent | |
| K142724 | BIOFOAM Bone Wedge | HRS | Substantially Equivalent | |
| K150213 | Subtalar Spacer System (STS) | HWC | Substantially Equivalent | |
| K150520 | DARCO Locking Bone Plate System | HRS | Substantially Equivalent | |
| K150252 | PHALINX Hammertoe System | HWC | Substantially Equivalent | |
| K142117 | INVISION TOTAL ANKLE REVISION SYSTEM | HSN | Substantially Equivalent | |
| K141740 | INFINITY (TM) TOTAL ANKLE SYSTEM; INBONE TOTAL ANKLE SYSTEM | HSN | Substantially Equivalent | |
| K150004 | SALVATION External Fixation System | KTT | Substantially Equivalent | |
| K150073 | MICRONAIL Distal Radius System | HSB | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- KTWAppliance, Fixation, Nail/Blade/Plate Combination, Single Component
- KWPAppliance, Fixation, Spinal Interlaminal
- KWQAppliance, Fixation, Spinal Intervertebral Body
- GFABlade, Saw, General & Plastic Surgery, Surgical
- MBIFastener, Fixation, Nondegradable, Soft Tissue
- MQVFiller, Bone Void, Calcium Compound
- MBPFiller, Bone Void, Osteoinduction (W/O Human Growth Factor)
- MLQInhibitor, Peridural Fibrosis (Adhesion Barrier)
- GCJLaparoscope, General & Plastic Surgery
- FTMMesh, Surgical
- OWYMesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
- MNHOrthosis, Spondylolisthesis Spinal Fixation
- HTYPin, Fixation, Smooth
- JDWPin, Fixation, Threaded
- HRSPlate, Fixation, Bone
- HSNProsthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
- KWIProsthesis, Elbow, Hemi-, Radial, Polymer
- JDBProsthesis, Elbow, Semi-Constrained, Cemented
- JDGProsthesis, Hip, Femoral Component, Cemented, Metal
- KXAProsthesis, Hip, Femoral, Resurfacing
- KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
- JDLProsthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)
- KWAProsthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
- LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
- MBLProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
- KROProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
- HRYProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
- MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
- JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
- KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
- KWDProsthesis, Toe, Hemi-, Phalangeal
- KYIProsthesis, Wrist, Carpal Trapezium
- KXEProsthesis, Wrist, Hemi-, Ulnar
- HSBRod, Fixation, Intramedullary And Accessories
- HWCScrew, Fixation, Bone
- JDRStaple, Fixation, Bone
- GATSuture, Nonabsorbable, Synthetic, Polyethylene
- FMFSyringe, Piston
- LJWTracheotome
- HTNWasher, Bolt Nut
- KGNWound Dressing With Animal-Derived Material(S)
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain