HAB
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Saw, Powered, And Accessories
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4820
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 2021: 1,719 · 2022: 387 · 2023: 734 · 2024: 746 · 2025: 479 · 2026: 263
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 |
|---|---|---|
| POWERPRO BATTERY SYSTEM (K012320) | Linvatec Corp. | 2001-10-19 |
| SNAP STERNUM SAW (K935517) | Surgiquip, Inc. | 1994-03-10 |
Track HAB automatically
Every clearance here is in the API, with alerts when new ones post.