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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 K120354
Device Name BETA-TCP GRANULES
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 Received02/06/2012
Decision Date 03/21/2013
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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