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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 K120760
Device Name LDR SPINE SPINETUNE TL SPINAL SYSTEM
Original Applicant
LDR SPINE USA INC.
13785 research boulevard
suite 200
austin,  TX  78750
Original Contact kiersten soderman
Regulation Number888.3070
Classification Product Code
MNH  
Subsequent Product Codes
KWP   MNI  
Date Received03/13/2012
Decision Date 06/27/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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