The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Ti. Alloy 2.0 Mm Cortex Screw.
Device ID | K952272 |
510k Number | K952272 |
Device Name: | TI. ALLOY 2.0 MM CORTEX SCREW |
Classification | Screw, Fixation, 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 | HWC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-05-15 |
Decision Date | 1995-07-31 |
Summary: | summary |