The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes 1.3 Mm Self-drilling Screw.
| Device ID | K983485 |
| 510k Number | K983485 |
| Device Name: | SYNTHES 1.3 MM SELF-DRILLING SCREW |
| Classification | Screw, Fixation, Intraosseous |
| Applicant | SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
| Contact | Sheri L Musgnung |
| Correspondent | Sheri L Musgnung SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
| Product Code | DZL |
| CFR Regulation Number | 872.4880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-05 |
| Decision Date | 1998-12-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H980400456E0 | K983485 | 000 |
| H980400455E0 | K983485 | 000 |
| H980400454E0 | K983485 | 000 |