The following data is part of a premarket notification filed by Synthes (usa) Products Llc with the FDA for Matrixrib Fixation System.
| Device ID | K133616 |
| 510k Number | K133616 |
| Device Name: | MATRIXRIB FIXATION SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | SYNTHES (USA) PRODUCTS LLC 1301 GOSHEN PKWY West Chester, PA 19380 |
| Contact | Damon Lees |
| Correspondent | Damon Lees SYNTHES (USA) PRODUCTS LLC 1301 GOSHEN PKWY 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 | 2013-11-25 |
| Decision Date | 2014-05-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H98004501030050 | K133616 | 000 |
| H980045010970 | K133616 | 000 |
| H980045010960 | K133616 | 000 |
| H98004501030010 | K133616 | 000 |