Submission Details
| 510(k) Number | K233874 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 07, 2023 |
| Decision Date | July 11, 2024 |
| Days to Decision | 217 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
K233874 is an FDA 510(k) clearance for the tmCMF Solution, a Plate, Bone (Class II — Special Controls, product code JEY), submitted by Techmah Cmf (Knoxville, US). The FDA issued a Cleared decision on July 11, 2024, 217 days after receiving the submission on December 7, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.4760.
| 510(k) Number | K233874 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 07, 2023 |
| Decision Date | July 11, 2024 |
| Days to Decision | 217 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 |