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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
Applicant
LDR SPINE USA INC.
13785 RESEARCH BOULEVARD
SUITE 200
AUSTIN,  TX  78750
Applicant Contact MARITZA ELIAS
Correspondent
LDR SPINE USA INC.
13785 RESEARCH BOULEVARD
SUITE 200
AUSTIN,  TX  78750
Correspondent 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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