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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 K212721
Device Name Genex Bone Graft Substitute
Applicant
Biocomposites, Ltd.
Keele Science Park
Keele,  GB ST5 5NL
Applicant Contact Simon Fitzer
Correspondent
Biocomposites, Ltd.
Keele Science Park
Keele,  GB ST5 5NL
Correspondent Contact Simon Fitzer
Regulation Number888.3045
Classification Product Code
MQV  
Date Received08/27/2021
Decision Date 02/04/2022
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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