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510(k) K161798

FacetBRIDGE® System by Ldr Spine USA, Inc. — Product Code MRW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 2016
Date Received
June 30, 2016
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Facet Screw Spinal Device
Device Class
Class U
Regulation Number
Review Panel
OR
Submission Type

Other clearances by Ldr Spine USA, Inc.

  • K162133 — VerteFIT Corpectomy Cage System (May 16, 2017)
  • K161173 — Avenue® T TLIF Cage (September 28, 2016)
  • K153495 — Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, (March 31, 2016)
  • K152137 — FacetBRIDGE System (January 25, 2016)
  • K151934 — ROI-C Titanium-Coated Implant System (December 7, 2015)
  • K150765 — LDR Spine ROI-C Cervical Cage System (September 17, 2015)
  • K142645 — Avenue T TLIF Cage (June 11, 2015)
  • K133363 — INTERBRIDGE INTERSPINOUS POSTERIOR FIXATION SYSTEM (March 7, 2014)
  • K123134 — EASYSPINE SYSTEM (February 1, 2013)
  • K121103 — LDR SPINE USA SPINE TUNE, TL SPINAL SYSTEM, LDR SPINE USA EASYSPINE, POSTERIOR S (August 24, 2012)

Other clearances for product code MRW

  • K251714 — Ion-C (January 16, 2026)
  • K250679 — FFX Facet Fixation System (December 4, 2025)
  • K253190 — CORUS-LX Implant (November 20, 2025)
  • K252153 — FFX Facet Fixation System (October 16, 2025)
  • K251885 — CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant (July 10, 2025)
  • K250920 — Arthrex Spine Compression FT Screw (May 22, 2025)
  • K242527 — The Karma® Fixation System (May 21, 2025)
  • K243865 — AERO MIS Facet Fusion System (March 24, 2025)
  • K243265 — Ion 3D (December 4, 2024)
  • K242650 — zLOCK Lumbar Facet Fixation System (September 20, 2024)