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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 K191943
Device Name SYMPHONY Navigation Ready Instruments, Universal Navigation Adaptor Set
Applicant
Medos International, SARL
Chemin-Blanc 38
le loche,  CH 2400
Applicant Contact daria bochenek
Correspondent
DePuy Synthes Spine
Eimattstrasse 3
oberdorf,  CH 4436
Correspondent Contact daria bochenek
Regulation Number882.4560
Classification Product Code
OLO  
Date Received07/22/2019
Decision Date 10/18/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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