The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Oribital Mesh Plates.
| Device ID | K001311 |
| 510k Number | K001311 |
| Device Name: | SYNTHES (USA) ORIBITAL MESH PLATES |
| Classification | Plate, Fixation, Bone |
| Applicant | SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
| Contact | Bonnie J Smith |
| Correspondent | Bonnie J Smith SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-25 |
| Decision Date | 2000-06-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H9804213040 | K001311 | 000 |
| H9804203030 | K001311 | 000 |
| H9804203040 | K001311 | 000 |
| H9804204010 | K001311 | 000 |
| H9804204020 | K001311 | 000 |
| H9804210480 | K001311 | 000 |
| H9804210490 | K001311 | 000 |
| H9804213020 | K001311 | 000 |
| H9804213030 | K001311 | 000 |
| H9804203020 | K001311 | 000 |