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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 K162567
Device Name ExactechGPS Total Shoulder Application, Equinoxe Planning Software
Blue Ortho
5 Avenue du Grand Sablon
La Tronche,  FR 38700
Applicant Contact Anthony Boyer
Blue Ortho
5 Avenue du Grand Sablon
La Tronche,  FR 38700
Correspondent Contact Anthony Boyer
Regulation Number882.4560
Classification Product Code
Subsequent Product Code
Date Received09/14/2016
Decision Date 04/05/2017
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