FacetBRIDGE® System

System, Facet Screw Spinal Device

LDR SPINE USA, INC.

The following data is part of a premarket notification filed by Ldr Spine Usa, Inc. with the FDA for Facetbridge® System.

Pre-market Notification Details

• Device ID: K161798
• 510k Number: K161798
• Device Name: FacetBRIDGE® System
• Classification: System, Facet Screw Spinal Device
• Applicant: LDR SPINE USA, INC. 13785 RESEARCH BLVD SUITE 200 Austin, TX 78750
• Contact: Jamie Wilson
• Correspondent: James E Wilson; LDR SPINE USA, INC. 13785 RESEARCH BLVD SUITE 200 Austin, TX 78750
• Product Code: MRW
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-06-30
• Decision Date: 2016-08-04
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
03662663029681	K161798	000
03662663029575	K161798	000
03662663029568	K161798	000
03662663029551	K161798	000
03662663029544	K161798	000
03662663029537	K161798	000
03662663029520	K161798	000
03662663029513	K161798	000
03662663029506	K161798	000
03662663029582	K161798	000
03662663029599	K161798	000
03662663029674	K161798	000
03662663029667	K161798	000
03662663029650	K161798	000
03662663029643	K161798	000
03662663029636	K161798	000
03662663029629	K161798	000
03662663029612	K161798	000
03662663029605	K161798	000
03662663029490	K161798	000