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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
510(k) Number K113609
Model 186-04-06/11/13, 186-05-08/11/13
Device Name NOVATION INTEGRIP ACETABULAR AUGMENTS, GROUPS 4 AND 5
Original Applicant
EXACTECH, INC.
2320 n.w. 66th ct.
gainesville,  FL  32653
Original Contact vladislava zaitseva
Regulation Number888.3358
Classification Product Code
LPH  
Date Received12/06/2011
Decision Date 01/04/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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