The following data is part of a premarket notification filed by Synthes (usa) with the FDA for 4.0/2.5 Mm Self-drilling Schanz Screw.
| Device ID | K002605 |
| 510k Number | K002605 |
| Device Name: | 4.0/2.5 MM SELF-DRILLING SCHANZ SCREW |
| Classification | Pin, Fixation, Threaded |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Contact | Bonnie J Smith |
| Correspondent | Bonnie J Smith SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Product Code | JDW |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-22 |
| Decision Date | 2000-11-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H6792947690 | K002605 | 000 |
| H6794947690 | K002605 | 000 |