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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Facet Screw Spinal Device
510(k) Number K152137
Device Name FacetBRIDGE System
Applicant
Ldr Spine USA
13785 Research Blvd., Suite 200
Austin,  TX  78750
Applicant Contact James Wilson
Correspondent
Ldr Spine USA
13785 Research Blvd., Suite 200
Austin,  TX  78750
Correspondent Contact Jamie E. Wilson
Classification Product Code
MRW  
Date Received07/31/2015
Decision Date 01/25/2016
Decision Substantially Equivalent (SESE)
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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