510(k) K262230
K262230 is an FDA 510(k) premarket notification submitted by Bone Solutions, Inc. for the device "Mg OSTEOREVIVE;Mg OSTEOCRETE". The FDA issued a decision of Substantially Equivalent on September 11, 2026. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Bone Solutions, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 11, 2026
- Date Received
- June 30, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Filler, Bone Void, Calcium Compound
- Device Class
- Class II
- Regulation Number
- 888.3045
- Review Panel
- OR
- Submission Type