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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 K161798
Device Name FacetBRIDGE® System
Applicant
Ldr Spine USA, Inc.
13785 Research Blvd., Suite 200
Austin,  TX  78750
Applicant Contact JAMIE WILSON
Correspondent
Ldr Spine USA, Inc.
13785 Research Blvd., Suite 200
Austin,  TX  78750
Correspondent Contact James E Wilson
Classification Product Code
MRW  
Date Received06/30/2016
Decision Date 08/04/2016
Decision Substantially Equivalent (SESE)
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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