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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 K111571
Device Name VIPER SYSTEMS
Applicant
Johnson & Johnson
325 Paramount Dr.
Raynham,  MA  02767
Applicant Contact DAPHNEY GERMAIN-KOLAWOLE
Correspondent
Johnson & Johnson
325 Paramount Dr.
Raynham,  MA  02767
Correspondent Contact DAPHNEY GERMAIN-KOLAWOLE
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   MNH   MNI  
Date Received06/06/2011
Decision Date 07/06/2011
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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