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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 K193098
Device Name Exactech® Equinoxe® Reverse Shoulder Glenospheres
Applicant
Exactech, Inc.
2320 NW 66th Court
Gainesville,  FL  32653
Applicant Contact Zach Sharrah
Correspondent
Exactech, Inc.
2320 NW 66th Court
Gainesville,  FL  32653
Correspondent Contact Zach Sharrah
Regulation Number888.3660
Classification Product Code
PHX  
Subsequent Product Codes
KWS   KWT  
Date Received11/07/2019
Decision Date 02/20/2020
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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