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Concorde Lift

by Medos International SARL 2 variants

510(k) K171425

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 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 NumberK171425 Date20 Jul 2017ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-1225-2019 FDA Class II initiated 8 Apr 2019

    A complaint trend was observed for post-operative loss of height and migration for Concorde Lift G3+ implants.

    • Terminated Z-0848-2018 FDA Class II initiated 26 Jul 2017

    Potential for Intra-operative breakage of driver tips

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  • Withdrawn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, 27 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 Concorde Lift is an expandable interbody device used in spinal fusion procedures. It is designed to be implanted via posterior, transforaminal, or lateral approaches to treat discogenic back pain with disc degeneration confirmed by history and radiographic studies in skeletally mature patients who have undergone a six-month course of conservative treatment.

The device is supplied as a sterile, single-use implant and has received FDA 510(k) clearance under K171425. It is intended for use in orthopedic spinal surgery and is regulated as a Class II medical device. No MRI safety information, storage conditions, or additional sizes are specified in the provided data.

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