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FDA 510(k) Application Details - K112857
Device Classification Name
Filler, Bone Void, Calcium Compound
More FDA Info for this Device
510(K) Number
K112857
Device Name
Filler, Bone Void, Calcium Compound
Applicant
BIOSTRUCTURES, LLC
11234 EL CAMINO REAL
SUITE 200
SAN DIEGO, CA 92130 US
Other 510(k) Applications for this Company
Contact
KEVIN A THOMAS
Other 510(k) Applications for this Contact
Regulation Number
888.3045
More FDA Info for this Regulation Number
Classification Product Code
MQV
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/30/2011
Decision Date
12/13/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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