The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) 1.0/1.22 Mm Craniofacial Screws.
| Device ID | K041887 |
| 510k Number | K041887 |
| Device Name: | SYNTHES (USA) 1.0/1.22 MM CRANIOFACIAL SCREWS |
| Classification | Screw, Fixation, Intraosseous |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Contact | Lisa M Boyle |
| Correspondent | Lisa M Boyle 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 | 2004-07-12 |
| Decision Date | 2004-08-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20887587043521 | K041887 | 000 |
| H980400412E0 | K041887 | 000 |
| H980400414E0 | K041887 | 000 |
| H980400422E0 | K041887 | 000 |
| H980400423E0 | K041887 | 000 |
| H980400470E0 | K041887 | 000 |
| H980400471E0 | K041887 | 000 |
| H980400472E0 | K041887 | 000 |
| H980400474E0 | K041887 | 000 |
| H9804004100 | K041887 | 000 |
| 20887587042791 | K041887 | 000 |
| 20887587042814 | K041887 | 000 |
| 20887587042838 | K041887 | 000 |
| 20887587042852 | K041887 | 000 |
| 20887587043460 | K041887 | 000 |
| 20887587043484 | K041887 | 000 |
| 20887587043507 | K041887 | 000 |
| H980400410E0 | K041887 | 000 |