JWI
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Prosthesis, Wrist, 2 Part Metal-Plastic Articulation, Semi-Constrained
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3800
- Medical specialty
- Orthopedic
- Flags
- Implant
- Adverse events (MAUDE)
- 2001: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| FIXANO TOTAL TRAPEZIO METACARPAL PROSTHESIS, 2ND (K931265) | Ferguson Medical | 1995-05-22 |
| UNIVERSAL WRIST (K940297) | Turnkey Intergration USA, Inc. | 1995-02-06 |
| ASPERGILLUS SP., ANTIGEN (K792687) | Meridian Diagnostics, Inc. | 1980-01-17 |
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Every clearance here is in the API, with alerts when new ones post.