HXN
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Applier, Cerclage
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.4540
- Medical specialty
- Orthopedic
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| OSTEO-CABLE SLEEVE (K024022) | Biomet, Inc. | 2003-01-23 |
| WIRE (K841628) | Plastafil, Inc. | 1984-07-23 |
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Every clearance here is in the API, with alerts when new ones post.