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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name prosthesis, shoulder, semi-constrained, metal/polymer cemented
510(k) Number K113309
Model 314-13-02/35
Device Name EXACTECH EQUINOXE CAGE GLENOIDS
Original Applicant
EXACTECH, INC.
2320 nw 66th court
gainesville,  FL  32605
Original Contact patrick hughes
Regulation Number888.3660
Classification Product Code
KWS  
Date Received11/08/2011
Decision Date 12/08/2011
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
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