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Nex-Link Spinal Fixation System

by Spinal Concepts, Inc.

510(k) K031985

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

4 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK031985 Date11 Sep 2003ClearedStatusActive

Recalls

4 recalls · FDA

  • 4 recalls, same reason

    • Terminated Z-0604-2011 FDA Unclassified (pre-2012) initiated 1 Dec 2005 on shared 510(k) K031985
    • Terminated Z-0605-2011 FDA Unclassified (pre-2012) initiated 1 Dec 2005 on shared 510(k) K031985
    • Terminated Z-0602-2011 FDA Unclassified (pre-2012) initiated 1 Dec 2005 on shared 510(k) K031985
    • Terminated Z-0603-2011 FDA Unclassified (pre-2012) initiated 1 Dec 2005 on shared 510(k) K031985

    The devices may fracture, resulting in surgical delay or the need for intervention to remove fragments from the surgical site.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

Full name
Spinal Concepts Inc. Nex-Link Spinal Fixation System
510(k) Number
FDA Product Code
MNI
Device Class
Class II
Regulation
21 CFR Part 888.3070
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Nex-Link Spinal Fixation System is a posterior cervico-thoracic system designed to promote fusion of the cervical and thoracic spine from C1 to T3. It consists of longitudinal members, hooks, and a range of screw diameters compatible with a 4.0mm diameter rod to address conditions including degenerative disc disease, spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion, and tumors.

This system features an occipital fixation option and is supplied for clinical use. It has received FDA 510(k) clearance under the traditional pathway. The device is categorized under product code MNI and is intended for use by medical professionals in appropriate surgical settings.

Other devices from Spinal Concepts, Inc.

See all devices from Spinal Concepts, Inc. →

Questions

AI-generated answers, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the intended use of the Nex-Link Spinal Fixation System?

    This system is a posterior cervico-thoracic fixation device designed to promote spinal fusion between the C1 and T3 vertebrae. It is indicated for treating conditions such as degenerative disc disease, spondylolisthesis, spinal stenosis, fractures, dislocations, tumors, and failed previous fusion procedures.

  • What components are included in the Nex-Link system?

    The system consists of longitudinal members, hooks, and a variety of screw diameters. These components are designed to be compatible with a 4.0mm diameter rod and include an option for occipital fixation to address specific clinical requirements in the cervical and thoracic regions.

  • What is the regulatory status of this spinal fixation system?

    The Nex-Link Spinal Fixation System has received FDA 510(k) clearance under the traditional pathway. It is categorized under product code MNI and is intended for use by qualified medical professionals within appropriate surgical settings.