NDF
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Plate, Fixation, Bone, Non-Spinal, Metallic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Medical specialty
- Orthopedic
- Flags
- Implant
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| FR.O.H. CALCANEUS REPAIR SYSTEM (K051642) | I.T.S. Implantat-Technologie-Systeme GmbH | 2005-08-22 |
| EBI DYNAFIX VS OSTEOTOMY SYSTEM (K021749) | Ebi, L.P. | 2002-08-12 |
| EBI DYNAFIX VS OSTEOTOMY SYSTEM (K010551) | Ebi, L.P. | 2001-05-17 |
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Every clearance here is in the API, with alerts when new ones post.