The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Proximal Femoral Nail(pfn) System Modification.
| Device ID | K973240 |
| 510k Number | K973240 |
| Device Name: | SYNTHES PROXIMAL FEMORAL NAIL(PFN) SYSTEM MODIFICATION |
| Classification | Pin, Fixation, Smooth |
| 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 | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-28 |
| Decision Date | 1997-11-20 |
| Summary: | summary |