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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 K231942
Device Name Mineral Collagen Composite Bioactive Extra Moldable
Applicant
Collagen Matrix, Inc.
15 Thornton Rd.
Oakland,  NJ  07436
Applicant Contact Victoria Augustine
Correspondent
Collagen Matrix, Inc.
15 Thornton Rd.
Oakland,  NJ  07436
Correspondent Contact Victoria Augustine
Regulation Number888.3045
Classification Product Code
MQV  
Date Received06/30/2023
Decision Date 08/02/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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