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 |