The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) [synthes] Point Contact Fixator Plate [pc-fix].
| Device ID | K951904 |
| 510k Number | K951904 |
| Device Name: | SYNTHES (USA) [SYNTHES] POINT CONTACT FIXATOR PLATE [PC-FIX] |
| Classification | Device, Fixation, Proximal Femoral, Implant |
| 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 | JDO |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-24 |
| Decision Date | 1995-07-17 |