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Talos Intervertebral Body Fusion Device

by Meditech Advisors, LLC

510(k) K090707

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

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 NumberK090707 Date15 Jul 2009ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

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

Overview

AI-generated summary, 24 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 Talos Intervertebral Body Fusion Device is a spinal implant made from PEEK-OPTIMA® material, featuring ridged teeth on superior and inferior surfaces to resist pullout and includes tantalum markers for radiographic positioning. It is available in four configurations (Talos-P, -T, -L, -A) with flat or lordotic angles to match patient anatomy. The device is designed to facilitate fusion in lumbar or cervical spine segments.

The Talos Intervertebral Body Fusion Device is implanted by surgeons via posterior, transforaminal, lateral, or other approaches as appropriate for the patient's condition. The device is supplied in various sizes and configurations to accommodate different anatomical requirements. It has received FDA 510(k) clearance with the product code MAX and is manufactured by Meditech Advisors, LLC.

Other devices from Meditech Advisors, LLC

Questions

AI-generated answers, 24 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 Talos Intervertebral Body Fusion Device used for?

    The Talos Intervertebral Body Fusion Device is a spinal implant designed to facilitate fusion in lumbar or cervical spine segments. It is made from PEEK-OPTIMA® material and features ridged surfaces to resist pullout, with tantalum markers for radiographic positioning.

  • What configurations are available for the Talos Intervertebral Body Fusion Device?

    The device is available in four configurations (Talos-P, -T, -L, -A) with flat or lordotic angles to match patient anatomy. Various sizes are supplied to accommodate different anatomical requirements.

  • How is the Talos Intervertebral Body Fusion Device implanted?

    The device is implanted by surgeons via posterior, transforaminal, lateral, or other approaches as appropriate for the patient's condition. The surgical approach depends on the specific clinical needs and anatomy of the patient.

  • What regulatory clearance has the Talos Intervertebral Body Fusion Device received?

    The Talos Intervertebral Body Fusion Device has received FDA 510(k) clearance with the product code MAX. It was determined to be substantially equivalent through the traditional clearance process.