The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Midface Distractor.
| Device ID | K010499 |
| 510k Number | K010499 |
| Device Name: | SYNTHES (USA) MIDFACE DISTRACTOR |
| Classification | Plate, Bone |
| 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 | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-21 |
| Decision Date | 2001-05-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10887587056050 | K010499 | 000 |
| 10887587055947 | K010499 | 000 |
| 10887587055954 | K010499 | 000 |
| 10887587055961 | K010499 | 000 |
| 10887587055978 | K010499 | 000 |
| 10887587055985 | K010499 | 000 |
| 10887587055992 | K010499 | 000 |
| 10887587056005 | K010499 | 000 |
| 10887587056012 | K010499 | 000 |
| 10887587055930 | K010499 | 000 |