The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes(usa)titanium Locking Plate System(tilps).
| Device ID | K970048 |
| 510k Number | K970048 |
| Device Name: | SYNTHES(USA)TITANIUM LOCKING PLATE SYSTEM(TILPS) |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
| Contact | Angela J Silvestri |
| Correspondent | Angela J Silvestri SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-06 |
| Decision Date | 1997-08-01 |
| Summary: | summary |