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 |