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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 K250521
Device Name NanoBone® SBX Putty ; NanoBone® QD
Applicant
Biocomposites, Ltd.
Keel Science Park
Keele,  GB ST55NL
Applicant Contact Ciara Airey
Correspondent
Bruder Consulting & Venture Group
38 True Harbour Way
West Islip,  NY  11795
Correspondent Contact Scott Bruder
Regulation Number888.3045
Classification Product Code
MQV  
Date Received02/21/2025
Decision Date 04/07/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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