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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
Applicant
Blue Ortho
5 Ave. Du Grand Sablon
La Tronche,  FR 38700
Applicant Contact Anthony Boyer
Correspondent
Blue Ortho
5 Ave. Du Grand Sablon
La Tronche,  FR 38700
Correspondent Contact Anthony Boyer
Regulation Number882.4560
Classification Product Code
OLO  
Subsequent Product Code
LLZ  
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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