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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 K111136
Device Name EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, 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   OSH  
Date Received04/22/2011
Decision Date 06/14/2012
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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