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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 K121220
Device Name EQUINOXE GLENOID, UHMWPE 16 PS=OSTERIOR AUGMENT PEGGED, SMALL, LEFT/RIGHT
Applicant
EXACTECH, INC.
2320 N.W. 66TH CT.
GAINESVILLE,  FL  32653
Applicant Contact LINDY KNISELY
Correspondent
EXACTECH, INC.
2320 N.W. 66TH CT.
GAINESVILLE,  FL  32653
Correspondent Contact LINDY KNISELY
Regulation Number888.3660
Classification Product Code
KWS  
Date Received04/23/2012
Decision Date 11/20/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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