HXP
5 FDA 510(k) clearances · Product code
7 daysmedian time to decision
86 days90th percentile
5clearances measured
FDA profile
- Official device name
- Instrument, Bending Or Contouring
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.4540
- Medical specialty
- Orthopedic
- Adverse events (MAUDE)
- 2013: 51 · 2014: 10 · 2015: 14 · 2021: 19
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 |
|---|---|---|
| WILLIAMS VERTEBRAL SPREADER (K872858) | Ace Medical Co. | 1987-10-15 |
| RETROGRADE KNIFE (K800730) | Stainless Mfg., Inc. | 1980-04-08 |
| DOUBLE-EDGE CURETTE (K800733) | Stainless Mfg., Inc. | 1980-04-08 |
| MENISCOTOME (K800732) | Stainless Mfg., Inc. | 1980-04-08 |
| MENISCAL SAW (K800731) | Stainless Mfg., Inc. | 1980-04-08 |
Track HXP automatically
Every clearance here is in the API, with alerts when new ones post.