K212570 is an FDA 510(k) clearance for the OsteoPlan System. This device is classified as a Driver, Wire, And Bone Drill, Manual (Class II - Special Controls, product code DZJ).
Submitted by Osteomed, LLC (Addison, US). The FDA issued a Cleared decision on February 11, 2022, 179 days after receiving the submission on August 16, 2021.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4120.
| 510(k) Number | K212570 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 16, 2021 |
| Decision Date | February 11, 2022 |
| Days to Decision | 179 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | DZJ - Driver, Wire, And Bone Drill, Manual |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.4120 |