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EBI SpineLink System

by Electro-Biology, Inc. 510(k)

Active United States

510(k) K964533

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK964533 Date9 Apr 1997ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • 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
MNH
Device Class
Class II
Regulation
21 CFR Part 888.3070
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The EBI SpineLink System is a spinal fixation device classified under orthopedic instrumentation, designed for stabilization of the non-cervical spine. It employs interconnecting links to provide immobilization as an adjunct to spinal fusion procedures. This device is intended for use in patients with severe spondylolisthesis of the fifth lumbar to first sacral (LS-S1) vertebral joint, specifically Grades 3 and 4. Its modular design allows for precise alignment and fixation of spinal segments during surgical interventions.

The EBI SpineLink System is supplied as a sterile, single-use orthopedic implant intended for surgical use in controlled clinical settings. Components are implanted to stabilize spinal segments, aiding in the fusion process for patients with degenerative or traumatic spinal instability. The system adheres to FDA 510(k) clearance (K964533) under the Traditional pathway, with product code MNH. Sterility and MRI safety are not specified in the available data, but it is intended for in vivo use only.

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Questions

AI-generated answers, 1 Oct 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 EBI SpineLink System used for in spinal surgery?

    The EBI SpineLink System is designed to stabilize severe spondylolisthesis at the fifth lumbar to first sacral (LS-S1) vertebral joint, specifically Grades 3 and 4. It employs interconnecting links to provide immobilization as part of spinal fusion procedures, helping restore alignment and support in patients with degenerative or traumatic spinal instability.

  • Is the EBI SpineLink System sterile and single-use?

    Yes, the EBI SpineLink System is supplied as a sterile, single-use orthopedic implant. This ensures safety and compliance with surgical standards, as it is intended for in vivo use only during controlled clinical procedures.

  • How is the modular design of the SpineLink System beneficial?

    The modular design allows for precise alignment and fixation of spinal segments, enabling surgeons to customize the system to the patient’s anatomy. This adaptability supports accurate placement during surgery, aiding in the fusion process for better long-term stability.

  • What regulatory pathway does the EBI SpineLink System follow?

    The EBI SpineLink System is cleared under the FDA’s Traditional 510(k) pathway (K964533) as substantially equivalent to a predicate device. It falls under product code MNH for orthopedic instrumentation, with clearance granted in 1997.

  • Can the SpineLink System be reused or stored for later use?

    The system is intended for single-use only and must be used immediately after opening in a sterile surgical environment. Reuse is not recommended due to potential contamination risks, and proper storage instructions should be followed to maintain sterility until implantation.