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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 K121989
Model 650-01-05, 01, -02, -05, -10, -20, 652-00-01, -02, -05, -10, -20
Device Name OPTECURE BONE VOID FILLER (0.5 CC, 1CC, 2CC, 5CC, 10CC, AND 20CC), OPTECURE + CCC BONE VOID FILLER (1CC, 2CC, 5CC, 10CC,
Original Applicant
EXACTECH, INC.
2320 n.w. 66th ct.
gainesville,  FL  32653
Original Contact gina cassidy
Regulation Number888.3045
Classification Product Code
MQV  
Subsequent Product Code
MBP  
Date Received07/06/2012
Decision Date 11/27/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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