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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, Non-Constrained, Metal/Polymer Cemented
510(k) Number K162903
Device Name Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies
Applicant
Exactech Inc
2320 NW 66th Court
Gainesville,  FL  32653
Applicant Contact Thomas McNamara
Correspondent
Exactech Inc
2320 NW 66th Court
Gainesville,  FL  32653
Correspondent Contact Thomas McNamara
Regulation Number888.3650
Classification Product Code
KWT  
Subsequent Product Codes
HSD   KWS   PHX  
Date Received10/17/2016
Decision Date 02/27/2017
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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