K210731 is an FDA 510(k) clearance for the KLS Martin Individual Patient Solutions. This device is classified as a Plate, Bone (Class II - Special Controls, product code JEY).
Submitted by KLS-Martin L.P. (Jacksonville, US). The FDA issued a Cleared decision on July 18, 2022, 494 days after receiving the submission on March 11, 2021.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4760.
| 510(k) Number | K210731 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 11, 2021 |
| Decision Date | July 18, 2022 |
| Days to Decision | 494 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 |