The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Titanium Multi-vector Distractor.
| Device ID | K010690 |
| 510k Number | K010690 |
| Device Name: | SYNTHES TITANIUM MULTI-VECTOR DISTRACTOR |
| Classification | Screw, Fixation, Intraosseous |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Contact | Thomas M Maguire |
| Correspondent | Thomas M Maguire 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 | 2001-03-08 |
| Decision Date | 2001-05-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10887587055923 | K010690 | 000 |
| 10887587055916 | K010690 | 000 |
| 10887587055909 | K010690 | 000 |
| 10887587055657 | K010690 | 000 |
| 10887587055640 | K010690 | 000 |
| 10887587055633 | K010690 | 000 |
| H980SD4879420 | K010690 | 000 |
| H980SD4879410 | K010690 | 000 |