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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 K170165
Device Name Osteo-P Bone Graft Substitute
Applicant
Molecular Matrix, Inc.
3410 Industrial Blvd., Suite 103
West Sacramento,  CA  95691
Applicant Contact Charles Lee
Correspondent
Kapstone Medical
P.O. Box 969
Leicester,  NC  28748
Correspondent Contact John Kapitan
Regulation Number888.3045
Classification Product Code
MQV  
Date Received01/19/2017
Decision Date 12/29/2017
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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