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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thoracolumbosacral Pedicle Screw System
510(k) Number K171570
Device Name Additional VIPER PRIME™ screws with fenestrations
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 Number888.3070
Classification Product Code
NKB  
Date Received05/30/2017
Decision Date 08/31/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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