The following data is part of a premarket notification filed by Synthes (usa) Products Llc with the FDA for Matrixrib Endo Thoracoscopic Rib Plating System.
| Device ID | K141241 |
| 510k Number | K141241 |
| Device Name: | MATRIXRIB ENDO THORACOSCOPIC RIB PLATING SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | SYNTHES (USA) PRODUCTS LLC 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
| Contact | Susan Lewandowski |
| Correspondent | Susan Lewandowski SYNTHES (USA) PRODUCTS LLC 1302 WRIGHTS LANE EAST 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 | 2014-05-13 |
| Decision Date | 2014-08-07 |
| Summary: | summary |