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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 K143659
Device Name Equinoxe Mega Prosthesis
Applicant
EXACTECH, INC.
2320 Northwest 66th Court
Gainesville,  FL  32653
Applicant Contact Thomas McNamara
Correspondent
EXACTECH, INC.
2320 Northwest 66th Court
Gainesville,  FL  32653
Correspondent Contact Thomas McNamara
Regulation Number888.3650
Classification Product Code
KWT  
Subsequent Product Codes
HSD   KWS   PHX  
Date Received12/23/2014
Decision Date 04/09/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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