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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 K083581
Device Name LANX SPINAL FIXATION SYSTEM
Applicant
LANX, INC.
390 INTERLOCKEN CRESCENT
SUITE 890
BROOMFIELD,  CO  80021
Applicant Contact ANDREW LAMBORNE
Correspondent
LANX, INC.
390 INTERLOCKEN CRESCENT
SUITE 890
BROOMFIELD,  CO  80021
Correspondent Contact ANDREW LAMBORNE
Regulation Number888.3070
Classification Product Code
MNH  
Subsequent Product Codes
KWP   MNI  
Date Received12/04/2008
Decision Date 04/07/2009
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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