The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) 1.3 Mm Craniofacial Screws.
| Device ID | K021850 |
| 510k Number | K021850 |
| Device Name: | SYNTHES (USA) 1.3 MM CRANIOFACIAL SCREWS |
| Classification | Screw, Fixation, Intraosseous |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Contact | Matthew M Hull |
| Correspondent | Matthew M Hull SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Product Code | DZL |
| CFR Regulation Number | 872.4880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-05 |
| Decision Date | 2002-06-10 |
| Summary: | summary |