K140462 is an FDA 510(k) clearance for the MATRIXNEURO PREFORMED MESH (PART OF THE MATRIXNEURO CRANIAL PLATING SYSTEM). This device is classified as a Plate, Cranioplasty, Preformed, Alterable (Class II - Special Controls, product code GWO).
Submitted by Synthes USA Products, LLC (West Chester, US). The FDA issued a Cleared decision on June 13, 2014, 109 days after receiving the submission on February 24, 2014.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5320.
| 510(k) Number | K140462 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 24, 2014 |
| Decision Date | June 13, 2014 |
| Days to Decision | 109 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GWO — Plate, Cranioplasty, Preformed, Alterable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5320 |