K240321 is an FDA 510(k) clearance for the MP Pin flat without thread (36BMP000020/MP20). This device is classified as a Screw, Fixation, Intraosseous (Class II - Special Controls, product code DZL).
Submitted by Hager& Meisinger GmbH (Neuss, DE). The FDA issued a Cleared decision on October 17, 2024, 258 days after receiving the submission on February 2, 2024.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4880.
| 510(k) Number | K240321 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 02, 2024 |
| Decision Date | October 17, 2024 |
| Days to Decision | 258 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | DZL — Screw, Fixation, Intraosseous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.4880 |