The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Midfacial System.
| Device ID | K953806 |
| 510k Number | K953806 |
| Device Name: | SYNTHES (USA) MIDFACIAL SYSTEM |
| Classification | Plate, Bone |
| Applicant | SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
| Contact | Angela J Silvestri |
| Correspondent | Angela J Silvestri SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-10 |
| Decision Date | 1996-03-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H980400433E0 | K953806 | 000 |
| H980400496E0 | K953806 | 000 |
| H980400498E0 | K953806 | 000 |
| H980400623E0 | K953806 | 000 |
| H980400624E0 | K953806 | 000 |
| H980400625E0 | K953806 | 000 |
| H980400626E0 | K953806 | 000 |
| H980400627E0 | K953806 | 000 |
| H980400628E0 | K953806 | 000 |
| H980400629E0 | K953806 | 000 |
| H980400630E0 | K953806 | 000 |
| H980400631E0 | K953806 | 000 |
| H980400632E0 | K953806 | 000 |
| H980400633E0 | K953806 | 000 |
| H980400634E0 | K953806 | 000 |
| H980400636E0 | K953806 | 000 |
| H980400638E0 | K953806 | 000 |
| H980400653E0 | K953806 | 000 |
| H980400494E0 | K953806 | 000 |
| H980400492E0 | K953806 | 000 |
| H980400490E0 | K953806 | 000 |
| H980400434E0 | K953806 | 000 |
| H980400435E0 | K953806 | 000 |
| H980400436E0 | K953806 | 000 |
| H980400438E0 | K953806 | 000 |
| H980400440E0 | K953806 | 000 |
| H980400442E0 | K953806 | 000 |
| H980400444E0 | K953806 | 000 |
| H980400446E0 | K953806 | 000 |
| H980400448E0 | K953806 | 000 |
| H980400453E0 | K953806 | 000 |
| H980400483E0 | K953806 | 000 |
| H980400484E0 | K953806 | 000 |
| H980400485E0 | K953806 | 000 |
| H980400486E0 | K953806 | 000 |
| H980400487E0 | K953806 | 000 |
| H980400488E0 | K953806 | 000 |
| H980400489E0 | K953806 | 000 |
| H980400654E0 | K953806 | 000 |
| H980400655E0 | K953806 | 000 |
| H980400656E0 | K953806 | 000 |
| 20887587044511 | K953806 | 000 |
| 20887587044535 | K953806 | 000 |
| 20887587044566 | K953806 | 000 |
| 20887587044580 | K953806 | 000 |
| 20887587044603 | K953806 | 000 |
| 20887587044627 | K953806 | 000 |
| 20887587044641 | K953806 | 000 |
| 20887587044665 | K953806 | 000 |
| 20887587044689 | K953806 | 000 |
| 20887587044702 | K953806 | 000 |
| 20887587044726 | K953806 | 000 |
| 20887587044740 | K953806 | 000 |
| 20887587044764 | K953806 | 000 |
| 20887587044788 | K953806 | 000 |
| 20887587044801 | K953806 | 000 |
| 20887587044825 | K953806 | 000 |
| 20887587044849 | K953806 | 000 |
| 20887587044498 | K953806 | 000 |
| 20887587044474 | K953806 | 000 |
| 20887587044450 | K953806 | 000 |
| H980400657E0 | K953806 | 000 |
| H980400658E0 | K953806 | 000 |
| H980400659E0 | K953806 | 000 |
| H980400660E0 | K953806 | 000 |
| H980400661E0 | K953806 | 000 |
| H980400662E0 | K953806 | 000 |
| H980400664E0 | K953806 | 000 |
| H980400666E0 | K953806 | 000 |
| H980400668E0 | K953806 | 000 |
| H9804200310 | K953806 | 000 |
| H9804210060 | K953806 | 000 |
| 10887587052410 | K953806 | 000 |
| 20887587044351 | K953806 | 000 |
| 20887587044375 | K953806 | 000 |
| 20887587044399 | K953806 | 000 |
| 20887587044412 | K953806 | 000 |
| 20887587044436 | K953806 | 000 |
| 20887587044863 | K953806 | 000 |