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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name orthopedic stereotaxic instrument
510(k) Number K213546
Device Name ExactechGPS Total Shoulder Application, Equinoxe Planning Software
Blue Ortho
22 Chemin du Vieux Chene
Meylan,  FR 38240
Applicant Contact Matthieu Coic
Blue Ortho
22 Chemin du Vieux Chene
Meylan,  FR 38240
Correspondent Contact Matthieu Coic
Regulation Number882.4560
Classification Product Code
Subsequent Product Code
Date Received11/08/2021
Decision Date 01/06/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls