NDL
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Pin, Fixation, Smooth, Metallic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Medical specialty
- Orthopedic
- Flags
- Implant
- Adverse events (MAUDE)
- 2009: 10 · 2026: 42
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 |
|---|---|---|
| K'FIX (K010847) | Avanta Orthopaedics, Inc. | 2001-06-19 |
| TBW (K010545) | Tri-Med, Inc. | 2001-06-06 |
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Every clearance here is in the API, with alerts when new ones post.