The following data is part of a premarket notification filed by Synthes (usa) Products Llc with the FDA for Matrixrib Fixation System.
| Device ID | K161590 |
| 510k Number | K161590 |
| Device Name: | MatrixRIB Fixation System |
| Classification | Plate, Fixation, Bone |
| Applicant | SYNTHES (USA) PRODUCTS LLC 1301 GOSHEN PARKWAY West Chester, PA 19380 |
| Contact | Thomas Shea |
| Correspondent | Thomas Shea SYNTHES (USA) PRODUCTS LLC 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 | 2016-06-09 |
| Decision Date | 2016-11-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10887587073385 | K161590 | 000 |
| H980045010940 | K161590 | 000 |
| H980045010950 | K161590 | 000 |
| 10887587073279 | K161590 | 000 |
| 10887587073286 | K161590 | 000 |
| 10887587073309 | K161590 | 000 |
| 10887587073316 | K161590 | 000 |
| 10887587073323 | K161590 | 000 |
| 10887587073330 | K161590 | 000 |
| 10887587073347 | K161590 | 000 |
| 10887587073354 | K161590 | 000 |
| 10887587073361 | K161590 | 000 |
| 10887587073378 | K161590 | 000 |
| H980045010930 | K161590 | 000 |