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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 K101993
Device Name VIPER SYSTEM, EXPEDIUM SYSTEM
Applicant
DEPUY SPINE, INC.
325 PARAMOUNT DR.
RAYNHAM,  MA  02767
Applicant Contact FRANK JURCZAK
Correspondent
DEPUY SPINE, INC.
325 PARAMOUNT DR.
RAYNHAM,  MA  02767
Correspondent Contact FRANK JURCZAK
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ   MNH   MNI  
Date Received07/15/2010
Decision Date 12/07/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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