The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes 1.0mm Ti. Cortex, Self-drilling Screws (carniofacial).
| Device ID | K050606 |
| 510k Number | K050606 |
| Device Name: | SYNTHES 1.0MM TI. CORTEX, SELF-DRILLING SCREWS (CARNIOFACIAL) |
| Classification | Screw, Fixation, Intraosseous |
| Applicant | SYNTHES (USA) 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
| Contact | Kathy Anderson |
| Correspondent | Kathy Anderson SYNTHES (USA) 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
| Product Code | DZL |
| CFR Regulation Number | 872.4880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-10 |
| Decision Date | 2005-04-06 |
| Summary: | summary |