HTX
5 FDA 510(k) clearances · Product code
28 daysmedian time to decision
154 days90th percentile
5clearances measured
FDA profile
- Official device name
- Rongeur
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.4540
- Medical specialty
- Orthopedic
- Adverse events (MAUDE)
- 2018: 25 · 2019: 24 · 2020: 29 · 2021: 26 · 2022: 23 · 2024: 24
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 |
|---|---|---|
| MANUAL RONGEUR (K874954) | Solway, Inc. | 1987-12-30 |
| FRONT RADIUS CUTTER (K841620) | Plastafil, Inc. | 1984-09-20 |
| BACK RADIUS CUTTER (K841621) | Plastafil, Inc. | 1984-09-20 |
| ORTHOPEDIC FORCEPS (K780397) | Orthopedic Equipment Co., Inc. | 1978-03-22 |
| SURGICAL INSTRUMENTS, ORTHOPEDIC (K760325) | Depuy, Inc. | 1976-08-03 |
Track HTX automatically
Every clearance here is in the API, with alerts when new ones post.