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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 K103419
Device Name EXACTECH EQUINOXE R UHMWPE POSTERIOR AUGMENT PEGGED GLENOIDS TM
Applicant
EXACTECH, INC.
2320 N.W. 66TH COURT
GAINESVILLE,  FL  32653
Applicant Contact PATRICK HUGHES
Correspondent
EXACTECH, INC.
2320 N.W. 66TH COURT
GAINESVILLE,  FL  32653
Correspondent Contact PATRICK HUGHES
Regulation Number888.3660
Classification Product Code
KWS  
Date Received11/22/2010
Decision Date 12/13/2010
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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