K192702 is an FDA 510(k) clearance for the DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional. This device is classified as a Plate, Cranioplasty, Preformed, Non-alterable (Class II - Special Controls, product code GXN).
Submitted by Synthes USA Products, LLC (West Chester, US). The FDA issued a Cleared decision on September 18, 2020, 357 days after receiving the submission on September 27, 2019.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5330.
| 510(k) Number | K192702 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 27, 2019 |
| Decision Date | September 18, 2020 |
| Days to Decision | 357 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GXN — Plate, Cranioplasty, Preformed, Non-alterable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5330 |