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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name prosthesis, shoulder, semi-constrained, metal/polymer cemented
510(k) Number K212356
Device Name Exactech® Equinoxe® Laser Cage Glenoid
Exactech, Inc.
2320 NW 66th Ct.
Gainesville,  FL  32653
Applicant Contact Kenneth C. Maxwell
Exactech, Inc.
2320 NW 66th Ct.
Gainesville,  FL  32653
Correspondent Contact Kenneth C. Maxwell
Regulation Number888.3660
Classification Product Code
Date Received07/29/2021
Decision Date 03/04/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls