The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) [synthes[ Self-drilling Schanz Screw.
Device ID | K952296 |
510k Number | K952296 |
Device Name: | SYNTHES (USA) [SYNTHES[ SELF-DRILLING SCHANZ 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 | 1995-05-16 |
Decision Date | 1995-08-18 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
H679SD2945600 | K952296 | 000 |
H679SD2940080 | K952296 | 000 |