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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
510(k) Number K192097
Device Name Exactech® Equinoxe® Stemless Humeral Components
Applicant
Exactech, Inc.
Gainsville,  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
PKC  
Date Received08/05/2019
Decision Date 04/29/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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