The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Proximal Femoral Nail (pfn) System.
| Device ID | K970097 |
| 510k Number | K970097 |
| Device Name: | PROXIMAL FEMORAL NAIL (PFN) SYSTEM |
| Classification | Pin, Fixation, Threaded |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301 |
| Contact | Sheri L Musgnung |
| Correspondent | Sheri L Musgnung SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301 |
| Product Code | JDW |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-13 |
| Decision Date | 1997-03-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H679030101150 | K970097 | 000 |
| H6793570390 | K970097 | 000 |