FDA Product Code
FDA Product Code JWJ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3800
510(k) Clearances — 17 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K243381 | Total Wrist Arthroplasty System (TWA) | Skeletal Dynamics, Inc. | 2024-11-01 | Special | PDF ↗ |
| K233574 | Total Wrist Arthroplasty System (TWA) | Skeletal Dynamics | 2024-07-03 | Traditional | PDF ↗ |
| K233674 | Freedom Wrist Arthroplasty System | Ascension Orthopedics, Inc. | 2024-05-30 | Traditional | PDF ↗ |
| K200718 | Arthrosurface WristMotion Total Wrist Arthroplasty System | Arthrosurface, Inc. | 2020-10-15 | Traditional | PDF ↗ |
| K191525 | KinematX Total Wrist Arthroplasty System | Extremity Medical, LLC | 2020-03-04 | Traditional | PDF ↗ |
| K132250 | INTEGRA FREEDOM WRIST ARTHROPLASTY SYSTEM | Integra LifeSciences Corporation | 2014-03-24 | Traditional | PDF ↗ |
| K080426 | MAESTRO WRIST FRACTURE IMPLANT | Biomet Manufacturing Corp | 2008-07-29 | Traditional | PDF ↗ |
| K042032 | MAESTRO TOTAL WRIST | Biomet, Inc. | 2004-10-07 | Traditional | PDF ↗ |
| K031203 | BIAX A.F. WRIST/BIAX ADVANCED FIXATION WRIST | DePuy Orthopaedics, Inc. | 2003-07-14 | Traditional | PDF ↗ |
| K030037 | UNIVERSAL TOTAL WRIST SYSTEM | Kinetikos Medical, Inc. | 2003-02-05 | Special | PDF ↗ |
| K021859 | WRIST IMPLANT | Avanta Orthopaedics, Inc. | 2002-12-02 | Traditional | PDF ↗ |
| K020554 | MODIFICATION TO UNIVERSAL TOTAL WRIST SYSTEM | Kinetikos Medical, Inc. | 2002-05-03 | Special | PDF ↗ |
| K982156 | PASCO MIC AND MIC/ID PANELS/ CEFDINIR | Pasco Laboratories, Inc. | 1998-07-29 | Traditional | PDF ↗ |
| K961051 | UNIVERSAL TOTAL WRIST SYSTEM (MODIFICATION) | Kinetikos Medical, Inc. | 1996-06-06 | Traditional | PDF ↗ |
| K931131 | THE RICHARDS WRIST | Smith & Nephew Richards, Inc. | 1994-08-19 | Traditional | PDF ↗ |
| K802032 | MINI MICK APPLICATOR | Mick Radio-Nuclear Instruments, Inc. | 1980-10-23 | Traditional | PDF ↗ |
| K792650 | HAMAS PRECENTERED TOTAL WRIST | Zimmer, Inc. | 1980-01-28 | Traditional | PDF ↗ |
Product code JWJ · Class II · Orthopedic. Data: openFDA.