The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Schuhli Implant System.
| Device ID | K954963 |
| 510k Number | K954963 |
| Device Name: | SCHUHLI IMPLANT SYSTEM |
| Classification | Plate, Fixation, Bone |
| 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 | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-30 |
| Decision Date | 1996-03-22 |
| Summary: | summary |