510(k) K233674
- Device
- Freedom Wrist Arthroplasty System
- Applicant
- Ascension Orthopedics, Inc.
- 510(k) number
- K233674
- Product code
- JWJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-05-30
- Date received
- 2023-11-16
- Regulation
- 888.3800
- Classification name
- Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Stephanie Rincones
- Address
- 11101 Metric Blvd. Austin TX US 78758 78758
FDA Registration Numbers
- 1450662
- 3006742481
- 3003477135
- 1825034
- 2133928
- 9680619
- 2245304
- 3013176080
- 3035366890
- 3005497913
- 3010060157
- 3009971621
- 1421101
- 2183744
- 3012028003
- 8031020
- 2183946
- 3002907620
- 8010379
- 2134285
- 3015207155
- 3004154314
- 1833920
- 1827096
- 2032521
- 3014207283
- 1043653
- 3007289093
- 1424263
- 3015516266
- 1526534
- 2029275
- 1828288
- 1226544
- 3014302784
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Other 510(k) Records For Product Code JWJ
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243381 | Total Wrist Arthroplasty System (TWA) | Skeletal Dynamics, Inc. | 2024-11-01 |
| K233574 | Total Wrist Arthroplasty System (TWA) | Skeletal Dynamics | 2024-07-03 |
| K200718 | Arthrosurface WristMotion Total Wrist Arthroplasty System | Arthrosurface, Inc. | 2020-10-15 |
| K191525 | KinematX Total Wrist Arthroplasty System | Extremity Medical, LLC | 2020-03-04 |
| K132250 | INTEGRA FREEDOM WRIST ARTHROPLASTY SYSTEM | Integra LifeSciences Corporation | 2014-03-24 |
| K080426 | MAESTRO WRIST FRACTURE IMPLANT | Biomet Manufacturing Corp | 2008-07-29 |
| K042032 | MAESTRO TOTAL WRIST | Biomet, Inc. | 2004-10-07 |
| K031203 | BIAX A.F. WRIST/BIAX ADVANCED FIXATION WRIST | DePuy Orthopaedics, Inc. | 2003-07-14 |
| K030037 | UNIVERSAL TOTAL WRIST SYSTEM | Kinetikos Medical, Inc. | 2003-02-05 |
| K021859 | WRIST IMPLANT | Avanta Orthopaedics, Inc. | 2002-12-02 |
| K020554 | MODIFICATION TO UNIVERSAL TOTAL WRIST SYSTEM | Kinetikos Medical, Inc. | 2002-05-03 |
| K982156 | PASCO MIC AND MIC/ID PANELS/ CEFDINIR | Pasco Laboratories, Inc. | 1998-07-29 |
| K961051 | UNIVERSAL TOTAL WRIST SYSTEM (MODIFICATION) | Kinetikos Medical, Inc. | 1996-06-06 |
| K931131 | THE RICHARDS WRIST | Smith & Nephew Richards, Inc. | 1994-08-19 |
| K802032 | MINI MICK APPLICATOR | Mick Radio-Nuclear Instruments, Inc. | 1980-10-23 |