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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 K161173
Device Name Avenue® T TLIF Cage
Applicant
Ldr Spine USA, Inc.
13785 Research Blvd., Suite 200
Austin,  TX  78750
Applicant Contact JOHN ROSSMAN
Correspondent
Ldr Spine USA, Inc.
13785 Research Blvd., Suite 200
Austin,  TX  78750
Correspondent Contact BRAD STRASSER
Regulation Number888.3080
Classification Product Code
OVD  
Date Received04/26/2016
Decision Date 09/28/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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