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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 K112857
Device Name INTERFACE BONE VOID FILLER
Applicant
BIOSTRUCTURES, LLC
11234 EL CAMINO REAL
SUITE 200
SAN DIEGO,  CA  92130
Applicant Contact KEVIN A THOMAS
Correspondent
BIOSTRUCTURES, LLC
11234 EL CAMINO REAL
SUITE 200
SAN DIEGO,  CA  92130
Correspondent Contact KEVIN A THOMAS
Regulation Number888.3045
Classification Product Code
MQV  
Date Received09/30/2011
Decision Date 12/13/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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