K954856 is an FDA 510(k) clearance for the CANNULATED FEMORAL NAIL. This device is classified as a Implant, Fixation Device, Spinal (Class II - Special Controls, product code JDN).
Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on March 8, 1996, 137 days after receiving the submission on October 23, 1995.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3060.
| 510(k) Number | K954856 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 23, 1995 |
| Decision Date | March 08, 1996 |
| Days to Decision | 137 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | JDN — Implant, Fixation Device, Spinal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3060 |