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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name shoulder prosthesis, reverse configuration
510(k) Number K110708
Device Name EQUINOXE REVERSE SHOULDER COMPRESSION SCREW / 38MM AND 42MM GLENOSPHERE / SUPERIOR AUGMENT GLENOID PLATE, 10 DEGREES...
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
PHX  
Subsequent Product Codes
KWS   KWT  
Date Received03/14/2011
Decision Date 04/01/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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