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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 K113434
Device Name LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS)
Applicant
LANX, INC.
210 INTERLOCKEN PARKWAY
SUITE 120
BROOMFIELD,  CO  80021
Applicant Contact MICHAEL FUNK
Correspondent
LANX, INC.
210 INTERLOCKEN PARKWAY
SUITE 120
BROOMFIELD,  CO  80021
Correspondent Contact MICHAEL FUNK
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   MNI  
Date Received11/21/2011
Decision Date 12/19/2011
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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