The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Synthes Mmfs-adjustable Sagittal Split Plate.
| Device ID | K964328 |
| 510k Number | K964328 |
| Device Name: | SYNTHES (USA) SYNTHES MMFS-ADJUSTABLE SAGITTAL SPLIT PLATE |
| Classification | Plate, Bone |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301 |
| Contact | Angela J Silvestri |
| Correspondent | Angela J Silvestri SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-30 |
| Decision Date | 1996-12-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10887587052922 | K964328 | 000 |
| 10887587052908 | K964328 | 000 |
| 10887587052885 | K964328 | 000 |