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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
Device Name EXACTECH EQUINOXE CAGE GLENOIDS
Applicant
EXACTECH, INC.
2320 NW 66TH COURT
GAINESVILLE,  FL  32605
Applicant Contact PATRICK HUGHES
Correspondent
EXACTECH, INC.
2320 NW 66TH COURT
GAINESVILLE,  FL  32605
Correspondent Contact PATRICK HUGHES
Regulation Number888.3660
Classification Product Code
KWS  
Date Received11/08/2011
Decision Date 12/08/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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