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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 K112383
Device Name CALLOS PROMODEL BONE VOID FILLER, SKAFFOLD MP (MACRO POROUS) BONE VOID FILLER
Applicant
SKELETAL KINETICS, LLC
10201 BUBB RD.
CUPERTINO,  CA  95014 -4167
Applicant Contact CHRISTINE KUO
Correspondent
SKELETAL KINETICS, LLC
10201 BUBB RD.
CUPERTINO,  CA  95014 -4167
Correspondent Contact CHRISTINE KUO
Regulation Number888.3045
Classification Product Code
MQV  
Date Received08/18/2011
Decision Date 02/07/2012
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
Recalls CDRH Recalls
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