Mg OSTEOREVIVE; Mg OSTEOCRETE— 510(k) K262230
Substantially EquivalentBone Solutions, Inc.
FDA 510(k) clearance K262230 for Mg OSTEOREVIVE; Mg OSTEOCRETE, Substantially Equivalent on 2026-09-11. Applicant: Bone Solutions, Inc.. Device class: 2.
Summary
This clearance covers two bone void fillers from Bone Solutions: Mg OSTEOREVIVE and Mg OSTEOCRETE. Both are filed under MQV, calcium compound bone void fillers. The "Mg" prefix points to a magnesium-based formulation, which sets Bone Solutions apart from the usual calcium phosphate and calcium sulfate products in this code.
Class II, 21 CFR 888.3045. The Orthopedic panel reviewed it as a Traditional 510(k).
Bone Solutions filed from Colleyville, Texas. Review took 73 days (June 30 to September 11, 2026).
Clearance details
- Device name as filed
- Mg OSTEOREVIVE;Mg OSTEOCRETE
- Applicant
- Bone Solutions, Inc.
- Product code
- Code MQV
- Device class
- Class 2
- Regulation
- 21 CFR 888.3045
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Colleyville, TX, US
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More clearances from Bone Solutions, Inc.
view allAdverse events under product code MQV
product code MQV- Death
- 6
- Injury
- 435
- Total
- 441
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.