HTT
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Burr, Orthopedic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.4540
- Medical specialty
- Orthopedic
- Adverse events (MAUDE)
- 2011: 9 · 2012: 16 · 2013: 6 · 2014: 7 · 2015: 17 · 2016: 9
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 |
|---|---|---|
| HALL STERILE BUR (K862529) | Hall Surgical, Division of Zimmer, Inc. | 1986-07-15 |
| MICRO-AIRE REPLAC. DRILL BURS FOR ZIMMER (K821695) | Micro-Aire Surgical Instruments, Inc. | 1982-07-20 |
| CARBIDE CUTTING INSTRUMENT/INTRAARTICU (K802598) | The Anspach Effort, Inc. | 1980-11-19 |
| BUR, SURGICAL CARBIDE (K760236) | Cutter Laboratories, Inc. | 1976-07-26 |
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Every clearance here is in the API, with alerts when new ones post.