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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Spondylolisthesis Spinal Fixation
510(k) Number K081296
Device Name PREFERENCE PEDICLE SCREW SYSTEM
Applicant
US SPINE
13540 GUILD AVE
APPLE VALLEY,  MN  55124
Applicant Contact RICHARD JANSEN, PHARM. D.
Correspondent
US SPINE
13540 GUILD AVE
APPLE VALLEY,  MN  55124
Correspondent Contact RICHARD JANSEN, PHARM. D.
Regulation Number888.3070
Classification Product Code
MNH  
Subsequent Product Codes
KWP   KWQ   MNI  
Date Received05/07/2008
Decision Date 06/06/2008
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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