The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Sterile 4.5 Mm Cannulated Screws.
Device ID | K963172 |
510k Number | K963172 |
Device Name: | SYNTHES STERILE 4.5 MM CANNULATED SCREWS |
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 For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-08-14 |
Decision Date | 1996-11-08 |
Summary: | summary |