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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 K090648
Device Name VIPER 2 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 Received03/11/2009
Decision Date 06/10/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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