ISS
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Prosthesis, Thigh Socket, External Component
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.3420
- Medical specialty
- Physical Medicine
- Flags
- GMP exempt
- Adverse events (MAUDE)
- 1993: 1 · 1998: 1 · 1999: 1 · 2006: 2 · 2007: 2 · 2009: 3
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 |
|---|---|---|
| A/K SOCKET (K802911) | Orthomedics | 1980-12-17 |
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Every clearance here is in the API, with alerts when new ones post.