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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 K260583
Device Name Equinoxe® Shoulder System
Applicant
Exactech, Inc.
2320 NW 66th Ct.
Gainesville,  FL  32653
Applicant Contact Pedro Ravelo
Correspondent
Advita Ortho
2320 NW 66th Ct.
Gainesville,  FL  32653
Correspondent Contact Pedro Ravelo
Regulation Number888.3660
Classification Product Code
PHX  
Subsequent Product Codes
KWS   KWT   PAO  
Date Received02/20/2026
Decision Date 04/14/2026
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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