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510(k) K253524

Adaptos®Fuse Bone Graft by Biomendex OY — Product Code MQV

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

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