K201944 is an FDA 510(k) clearance for the DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm). 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 September 10, 2020, 59 days after receiving the submission on July 13, 2020.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4760.
| 510(k) Number | K201944 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 13, 2020 |
| Decision Date | September 10, 2020 |
| Days to Decision | 59 days |
| Submission Type | Special |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | JEY — Plate, Bone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.4760 |