HWK
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Trephine
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.4540
- Medical specialty
- Orthopedic
- Adverse events (MAUDE)
- 2008: 6 · 2010: 5 · 2013: 13 · 2018: 14 · 2019: 12 · 2020: 13
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 |
|---|---|---|
| PRECISION HARVEST & INLAY INSTRUMENT SET (K851339) | Concept, Inc. | 1985-07-02 |
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