HXS
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Twister, Wire
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.4540
- Medical specialty
- Orthopedic
- Adverse events (MAUDE)
- 1997: 1 · 2005: 2
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 |
|---|---|---|
| KLEIN WIRE TIGHTENER/BIONIC WIRE (K833726) | Bionic Instrument Corp. | 1983-12-22 |
| FLAT WRENCH (K781451) | Orthopedic Equipment Co., Inc. | 1978-09-27 |
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Every clearance here is in the API, with alerts when new ones post.