The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Sterile 2.7 Mm Reconstruction Plates.
| Device ID | K974908 |
| 510k Number | K974908 |
| Device Name: | SYNTHES STERILE 2.7 MM RECONSTRUCTION PLATES |
| Classification | Plate, Fixation, Bone |
| Applicant | SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
| Contact | Kevin J O'connell |
| Correspondent | Kevin J O'connell 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 | 1997-12-31 |
| Decision Date | 1998-03-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H67924527S0 | K974908 | 000 |
| H67924521S0 | K974908 | 000 |
| H67924522S0 | K974908 | 000 |
| H67924523S0 | K974908 | 000 |
| H67924526S0 | K974908 | 000 |
| H67924528S0 | K974908 | 000 |
| H67924529S0 | K974908 | 000 |
| H67924524S0 | K974908 | 000 |
| H67924525S0 | K974908 | 000 |
| H67924520S0 | K974908 | 000 |