The following data is part of a premarket notification filed by Depuy Synthes with the FDA for Matrixrib Fixation System.
| Device ID | K190409 |
| 510k Number | K190409 |
| Device Name: | MatrixRIB Fixation System |
| Classification | Plate, Fixation, Bone |
| Applicant | DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 |
| Contact | Francoise Cettour-delbart |
| Correspondent | Francoise Cettour-delbart DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-21 |
| Decision Date | 2019-05-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10887587074382 | K190409 | 000 |
| H98004501210010 | K190409 | 000 |
| H98004501212010 | K190409 | 000 |
| H98004501214010 | K190409 | 000 |
| H98004501216010 | K190409 | 000 |
| H98004501218010 | K190409 | 000 |
| H98004501220010 | K190409 | 000 |
| 10887587073439 | K190409 | 000 |
| 10887587073446 | K190409 | 000 |
| 07612334110947 | K190409 | 000 |
| 07612334118653 | K190409 | 000 |
| 10887587074337 | K190409 | 000 |
| 10887587074344 | K190409 | 000 |
| 10887587074351 | K190409 | 000 |
| 10887587074368 | K190409 | 000 |
| 10887587074375 | K190409 | 000 |
| H98004501208010 | K190409 | 000 |