Skip to content

Stable-L Standalone Lumbar Interbody System, Stable-C Interbody System

by Nexus Spine, LLC 510(k)

Active United States

510(k) K232530

Overview

The Stable-L Standalone Lumbar Interbody System and Stable-C Interbody System are orthopedic devices designed for spinal fusion procedures in the lumbar region. These systems are intended to provide stabilization between vertebrae to facilitate bone growth and spinal fusion.

The devices are supplied in various sizes and are designed for single-use or reusable applications depending on the specific model. They are manufactured by Nexus Spine, LLC and have received FDA 510(k) clearance with the product code OVD. The devices are intended for use in orthopedic procedures and should be stored according to the manufacturer's instructions.

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 · Special NumberK232530 Date18 Sep 2023ClearedStatusActive

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 purpose of the Stable-L Standalone Lumbar Interbody System?

    The Stable-L Standalone Lumbar Interbody System and Stable-C Interbody System are orthopedic devices designed for spinal fusion procedures in the lumbar region. They provide stabilization between vertebrae to facilitate bone growth and spinal fusion.

  • Are these devices single-use or reusable?

    The devices are supplied in various sizes and are designed for either single-use or reusable applications depending on the specific model. Users should refer to the specific model's instructions for proper usage guidelines.

  • What regulatory clearance has been obtained for these devices?

    The Stable-L Standalone Lumbar Interbody System and Stable-C Interbody System have received FDA 510(k) clearance with the product code OVD. They were cleared as substantially equivalent devices through the special review process.

  • How should these devices be stored?

    The devices should be stored according to the manufacturer's instructions. Proper storage conditions are essential to maintain the integrity and functionality of the orthopedic devices until they are ready for use in spinal fusion procedures.