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 |