The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) External Multi Vector Mandible Distractor.
| Device ID | K981362 |
| 510k Number | K981362 |
| Device Name: | SYNTHES (USA) EXTERNAL MULTI VECTOR MANDIBLE DISTRACTOR |
| 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 | 1998-04-15 |
| Decision Date | 1998-06-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20887587029693 | K981362 | 000 |
| 10887587055497 | K981362 | 000 |
| 10887587055510 | K981362 | 000 |
| 10887587055534 | K981362 | 000 |
| 10887587055558 | K981362 | 000 |
| 10887587055572 | K981362 | 000 |
| 10887587055596 | K981362 | 000 |
| 10887587055619 | K981362 | 000 |
| 10887587055848 | K981362 | 000 |
| 10887587055855 | K981362 | 000 |
| 10887587055862 | K981362 | 000 |
| 10887587055879 | K981362 | 000 |
| H9803955750 | K981362 | 000 |