The following data is part of a premarket notification filed by Synthes (usa) Products Llc with the FDA for Matrixneuro Preformed Mesh (part Of The Matrixneuro Cranial Plating System).
| Device ID | K140462 |
| 510k Number | K140462 |
| Device Name: | MATRIXNEURO PREFORMED MESH (PART OF THE MATRIXNEURO CRANIAL PLATING SYSTEM) |
| Classification | Plate, Cranioplasty, Preformed, Alterable |
| Applicant | SYNTHES (USA) PRODUCTS LLC 1301 GOSHEN PKWY. West Chester, PA 19380 |
| Contact | Alan T Haley |
| Correspondent | Alan T Haley SYNTHES (USA) PRODUCTS LLC 1301 GOSHEN PKWY. West Chester, PA 19380 |
| Product Code | GWO |
| CFR Regulation Number | 882.5320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-24 |
| Decision Date | 2014-06-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H98004503158S0 | K140462 | 000 |
| H98004503157S0 | K140462 | 000 |
| H98004503156S0 | K140462 | 000 |
| H98004503155S0 | K140462 | 000 |
| H98004503152S0 | K140462 | 000 |
| H98004503151S0 | K140462 | 000 |