K192655 is an FDA 510(k) clearance for the Depuy Synthes Maxillofacial Portfolio - MR Conditional. This device is classified as a Plate, Bone (Class II - Special Controls, product code JEY).
Submitted by Synthes USA Products, LLC (West Chester, US). The FDA issued a Cleared decision on December 30, 2019, 96 days after receiving the submission on September 25, 2019.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4760.
| 510(k) Number | K192655 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 25, 2019 |
| Decision Date | December 30, 2019 |
| Days to Decision | 96 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | JEY — Plate, Bone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.4760 |