The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Midface Distractor.
| Device ID | K022005 |
| 510k Number | K022005 |
| Device Name: | SYNTHES MIDFACE DISTRACTOR |
| Classification | Plate, Bone |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Contact | Matthew M Hull |
| Correspondent | Matthew M Hull 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 | 2002-06-19 |
| Decision Date | 2002-09-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10887587056043 | K022005 | 000 |
| 10887587056036 | K022005 | 000 |
| 10887587056029 | K022005 | 000 |
| 10887587055824 | K022005 | 000 |
| 10887587055800 | K022005 | 000 |
| 10887587055787 | K022005 | 000 |
| 10887587055763 | K022005 | 000 |