The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes 1.5mm Ti Brow Lift Screw.
| Device ID | K002935 |
| 510k Number | K002935 |
| Device Name: | SYNTHES 1.5MM TI BROW LIFT SCREW |
| Classification | Screw, Fixation, Intraosseous |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Contact | Thomas M Maguire |
| Correspondent | Thomas M Maguire SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Product Code | DZL |
| CFR Regulation Number | 872.4880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-21 |
| Decision Date | 2000-11-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H9804007010 | K002935 | 000 |