The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Low Profile Neuro System - 3 Mm Screws.
| Device ID | K031807 |
| 510k Number | K031807 |
| Device Name: | SYNTHES LOW PROFILE NEURO SYSTEM - 3 MM SCREWS |
| Classification | Screw, Fixation, Intraosseous |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Contact | Bonnie J Smith |
| Correspondent | Bonnie J Smith 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 | 2003-06-11 |
| Decision Date | 2003-07-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H9804008530 | K031807 | 000 |
| H9804008430 | K031807 | 000 |
| H9804008330 | K031807 | 000 |
| H980400853E0 | K031807 | 000 |
| H980400843E0 | K031807 | 000 |
| H980400833E0 | K031807 | 000 |