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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name orthosis, spinal pedicle fixation, for degenerative disc disease
510(k) Number K112931
Device Name LEUCADIA(TM) MIS PEDICLE SCREW SYSTEM
Original Applicant
PHYGEN, LLC
2301 dupont drive, suite 510
irvine,  CA  92612
Original Contact hartmut loch
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ   MNH   MNI  
Date Received10/03/2011
Decision Date 11/02/2011
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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