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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name intervertebral fusion device with integrated fixation, lumbar
510(k) Number K113285
Device Name LDR SPINE USA AVENUE L INTERBODY FUSION
Original Applicant
LDR SPINE USA INC.
13785 research boulevard
suite 200
austin,  TX  78750
Original Contact maritza elias
Regulation Number888.3080
Classification Product Code
OVD  
Date Received11/07/2011
Decision Date 07/26/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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