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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 K170937
Device Name VIPER PRIME navigated inserter
Applicant
Medos International SARL
Chemin-Blanc 38
Lelocle,  CH 2400
Applicant Contact Karen Sylvia
Correspondent
DePuy Synthes
325 Paramount Dr.
Raynham,  MA  02767
Correspondent Contact Laura Bleyendaal
Regulation Number882.4560
Classification Product Code
OLO  
Date Received03/30/2017
Decision Date 09/14/2017
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
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