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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 K121316
Device Name LANX SPINAL FIZATION SYSTEM
Original Applicant
LANX, INC.
310 interlocken parkway
suite 120
broomfield,  CO  80021
Original Contact william sandul
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   MNH   MNI  
Date Received05/08/2012
Decision Date 09/10/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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