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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 K223833
Device Name Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter Trays
Applicant
Exactech, Inc
2320 NW 66th CT
Gainesville,  FL  32653
Applicant Contact Liz Howell
Correspondent
Exactech, Inc
2320 NW 66th CT
Gainesville,  FL  32653
Correspondent Contact Liz Howell
Regulation Number888.3660
Classification Product Code
PHX  
Subsequent Product Codes
KWS   KWT  
Date Received12/22/2022
Decision Date 09/14/2023
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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