The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Curved Reconstruction Plate.
| Device ID | K011334 |
| 510k Number | K011334 |
| Device Name: | SYNTHES CURVED RECONSTRUCTION PLATE |
| Classification | Plate, Fixation, Bone |
| Applicant | SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
| Contact | Matthew M Hall |
| Correspondent | Matthew M Hall 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 | 2001-05-02 |
| Decision Date | 2001-07-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H6792454810 | K011334 | 000 |
| H6792454610 | K011334 | 000 |
| H6792454410 | K011334 | 000 |
| H6792454210 | K011334 | 000 |
| H6792454010 | K011334 | 000 |
| H6792453810 | K011334 | 000 |
| H6792453610 | K011334 | 000 |
| H6792453410 | K011334 | 000 |