The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) New/sterial Orbital Plates.
| Device ID | K031761 |
| 510k Number | K031761 |
| Device Name: | SYNTHES (USA) NEW/STERIAL ORBITAL PLATES |
| Classification | Plate, Bone |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301 |
| Contact | Lisa Boyle |
| Correspondent | Lisa Boyle SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 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 | 2003-06-06 |
| Decision Date | 2003-09-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10887587051734 | K031761 | 000 |
| H98042045S0 | K031761 | 000 |
| H9804210400 | K031761 | 000 |
| H9804210430 | K031761 | 000 |
| H9804210440 | K031761 | 000 |
| H980421044S0 | K031761 | 000 |
| H9804210450 | K031761 | 000 |
| H980421045S0 | K031761 | 000 |
| 10887587051697 | K031761 | 000 |
| 10887587051710 | K031761 | 000 |
| H9804204030 | K031761 | 000 |