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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 K122145
Device Name LANX SPINAL FIXATION SYSTEM
Applicant
LANX, INC.
310 INTERLOCKEN PARKWAY
SUITE 120
BROOMFIELD,  CO  80021
Applicant Contact MICHAEL FUNK
Correspondent
LANX, INC.
310 INTERLOCKEN PARKWAY
SUITE 120
BROOMFIELD,  CO  80021
Correspondent Contact MICHAEL FUNK
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   MNH   MNI  
Date Received07/19/2012
Decision Date 08/17/2012
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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