Skip to content

Stable-L Standalone Lumbar Interbody System

by Nexus Spine, LLC 510(k)

Active United States

510(k) K212498

Overview

The Stable-L Standalone Lumbar Interbody System is a device used for spinal fusion procedures in the lumbar region. It provides stability between vertebrae and is designed for rapid fixation with features such as self-starting screws and a self-actuating anti-backout mechanism.

This system is supplied as a standalone device and is available with optional coverplate and rapid attachment inserter. The device is MRI safe and has received FDA 510(k) clearance with the product code OVD. It is manufactured by Nexus Spine, LLC and is indicated for use in skeletally mature patients requiring lumbar interbody fusion.

AI-generated from registry data, 23 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK212498 Date18 Mar 2022ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
OVD
Device Class
Class II
Regulation
21 CFR Part 888.3080
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Other devices from Nexus Spine, LLC.

See all devices from Nexus Spine, LLC. →

Questions

  • What is the Stable-L Standalone Lumbar Interbody System used for?

    It is indicated for spinal fusion procedures in the lumbar region of skeletally mature patients. The device provides intervertebral stability and is designed to facilitate rapid fixation during lumbar interbody fusion surgeries.

  • How is the Stable-L system supplied?

    It is supplied as a standalone device. Optional components include a coverplate and a rapid attachment inserter to support surgical efficiency and precise implant placement.

  • Is the Stable-L device MRI safe?

    Yes, the Stable-L Standalone Lumbar Interbody System is MRI safe, making it compatible with postoperative imaging when clinically indicated.

  • What design features aid in surgical efficiency?

    The system incorporates self-starting screws to simplify insertion and a self-actuating anti-backout mechanism to help maintain implant position and reduce the risk of migration after placement.

  • Who manufactures the Stable-L device?

    The Stable-L Standalone Lumbar Interbody System is manufactured by Nexus Spine, LLC, based in Salt Lake City, Utah, USA.