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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 K113366
Device Name LEUCADIA AUTOLOK PEDICLE SCREW SYSTEM
Applicant
PHYGEN, LLC
2301 DUPONT DRIVE, SUITE 510
IRVINE,  CA  92612
Applicant Contact HARTMUT LOCH
Correspondent
PHYGEN, LLC
2301 DUPONT DRIVE, SUITE 510
IRVINE,  CA  92612
Correspondent Contact HARTMUT LOCH
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ   MNH   MNI  
Date Received11/15/2011
Decision Date 01/17/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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