HXL
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Mallet
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 1997: 1 · 1998: 1 · 2000: 1 · 2007: 3 · 2011: 8 · 2012: 7
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 |
|---|---|---|
| MALLET, SURGICAL (K882349) | Treace Medical, Inc. | 1988-06-23 |
| ARTHROPLASTY MALLET (K872209) | New England Surgical Instrument Corp. | 1987-06-23 |
| MALLET, BONE SURGERY, STAINLESS STEEL, 2LB. (K871195) | Military Engineering, Inc. | 1987-04-06 |
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Every clearance here is in the API, with alerts when new ones post.