Submission Details
| 510(k) Number | K210731 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
KLS Martin Individual Patient Solutions
Jul 2022
Decision
494d
Days
Class 2
Risk
About This 510(k) Submission
K210731 is an FDA 510(k) clearance for the KLS Martin Individual Patient Solutions, 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 review panel. Regulated under 21 CFR 872.4760.
Device Classification
| Product Code | JEY — Plate, Bone |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 872.4760 |
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