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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filler, Bone Void, Calcium Compound
510(k) Number K253524
Device Name Adaptos®Fuse Bone Graft
Applicant
Biomendex OY
Korkeakoulunkatu 1
Tampere,  FI 33720
Applicant Contact Pasi Kankaanpää
Correspondent
Bruder Consulting & Venture Group
38 True Harbour Way
West Islip,  NY  11795
Correspondent Contact Susan Drapeau
Regulation Number888.3045
Classification Product Code
MQV  
Date Received11/13/2025
Decision Date 02/17/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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