510(k) K113285

LDR SPINE USA AVENUE L INTERBODY FUSION by Ldr Spine USA, Inc. — Product Code OVD

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: July 26, 2012
Date Received: November 7, 2011
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Intervertebral Fusion Device With Integrated Fixation, Lumbar
Device Class: Class II
Regulation Number: 888.3080
Review Panel: OR
Submission Type

Intended to stabilize lumbar spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.

Other clearances by Ldr Spine USA, Inc.

K162133 — VerteFIT Corpectomy Cage System (May 16, 2017)
K161173 — Avenue® T TLIF Cage (September 28, 2016)
K161798 — FacetBRIDGE® System (August 4, 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)

Other clearances for product code OVD

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K251829 — DeGen Medical Patient Specific Implant (PSI) System (December 8, 2025)
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K250072 — CONDUIT SYNFIX Evolution Secured Spacer System (July 10, 2025)
K251644 — ProAM ALIF System (June 24, 2025)
K250845 — Curiteva Porous PEEK Standalone ALIF System (June 18, 2025)
K251459 — OneLIF Interbody Fusion System (June 12, 2025)
K243934 — Stable-L Lumbar Interbody System (April 30, 2025)
K243386 — Ventris Intervertebral Body Fusion Device (April 22, 2025)
K250603 — AxTiHA® Stand-Alone ALIF System (March 24, 2025)