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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 K233482
Device Name Equinoxe® Central Screw Baseplate System
Applicant
Exactech, Inc.
2320 NW 66th Court
Gainesville,  FL  32653
Applicant Contact Liz Howell
Correspondent
Exactech, Inc.
2320 NW 66th Court
Gainesville,  FL  32653
Correspondent Contact Liz Howell
Regulation Number888.3660
Classification Product Code
PHX  
Subsequent Product Code
KWT  
Date Received10/26/2023
Decision Date 07/18/2024
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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