The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Cannulated Femoral Nail.
| Device ID | K954856 |
| 510k Number | K954856 |
| Device Name: | CANNULATED FEMORAL NAIL |
| Classification | Implant, Fixation Device, Spinal |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Contact | Angela J Silvestri |
| Correspondent | Angela J Silvestri SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Product Code | JDN |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-23 |
| Decision Date | 1996-03-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H679474921S0 | K954856 | 000 |
| H679474338S0 | K954856 | 000 |
| H679474336S0 | K954856 | 000 |
| H679474334S0 | K954856 | 000 |
| H679474244S0 | K954856 | 000 |
| H679474242S0 | K954856 | 000 |
| H679474146S0 | K954856 | 000 |
| H679474144S0 | K954856 | 000 |
| H679474142S0 | K954856 | 000 |
| H679474141S0 | K954856 | 000 |
| H679474138S0 | K954856 | 000 |
| H679474136S0 | K954856 | 000 |
| H679474134S0 | K954856 | 000 |
| H679474044S0 | K954856 | 000 |
| H679474042S0 | K954856 | 000 |
| H679474038S0 | K954856 | 000 |
| H679474031S0 | K954856 | 000 |
| H679474341S0 | K954856 | 000 |
| H679474532S0 | K954856 | 000 |
| H679474536S0 | K954856 | 000 |
| H679474920S0 | K954856 | 000 |
| H679474913S0 | K954856 | 000 |
| H6794749130 | K954856 | 000 |
| H679474912S0 | K954856 | 000 |
| H6794749120 | K954856 | 000 |
| H679474911S0 | K954856 | 000 |
| H6794749110 | K954856 | 000 |
| H6794749100 | K954856 | 000 |
| H679474900S0 | K954856 | 000 |
| H6794749000 | K954856 | 000 |
| H679474048S0 | K954856 | 000 |
| H6794749220 | K954856 | 000 |
| H6794749210 | K954856 | 000 |
| H6794749200 | K954856 | 000 |
| H679474922S0 | K954856 | 000 |
| H679474541S0 | K954856 | 000 |
| H679474910S0 | K954856 | 000 |