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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 K173372
Device Name ExactechGPS Total Shoulder Application
Applicant
Blue Ortho
6 Allee De Bethleem
Gieres,  FR 38610
Applicant Contact Anthony Boyer
Correspondent
Blue Ortho
6 Allee De Bethleem
Gieres,  FR 38610
Correspondent Contact Anthony Boyer
Regulation Number882.4560
Classification Product Code
OLO  
Subsequent Product Code
LLZ  
Date Received10/27/2017
Decision Date 11/24/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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