K234013 is an FDA 510(k) clearance for the Mg OSTEOINJECT™. This device is classified as a Filler, Bone Void, Calcium Compound (Class II - Special Controls, product code MQV).
Submitted by Bone Solutions, Inc. (Colleyville, US). The FDA issued a Cleared decision on February 5, 2024, 48 days after receiving the submission on December 19, 2023.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3045.
| 510(k) Number | K234013 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 19, 2023 |
| Decision Date | February 05, 2024 |
| Days to Decision | 48 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | MQV - Filler, Bone Void, Calcium Compound |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3045 |