510(k) K253524
K253524 is an FDA 510(k) premarket notification submitted by Biomendex OY for the device "Adaptos®Fuse Bone Graft". The FDA issued a decision of Substantially Equivalent on February 17, 2026. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 17, 2026
- Date Received
- November 13, 2025
- 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