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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 K150458
Device Name Exactech Equinoxe Reverse Shoulder 46x21mm Glenosphere
Applicant
EXACTECH, INC.
2320 N.W. 66TH CT.
GAINESVILLE,  FL  32653
Applicant Contact Thomas McNamara
Correspondent
EXACTECH, INC.
2320 N.W. 66TH CT.
GAINESVILLE,  FL  32653
Correspondent Contact Thomas McNamara
Regulation Number888.3660
Classification Product Code
PHX  
Date Received02/23/2015
Decision Date 05/14/2015
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
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