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Concorde Bullet Lumbar Interbody System

by Medos International SARL EUDAMED510(k)

Active European Union and United States

510(k) K151773

Overview

The Concorde Bullet Lumbar Interbody System is an intervertebral body fusion device designed for lumbar spine applications. It consists of polymer/carbon fiber composite cages engineered to facilitate spinal stabilization and bone fusion in skeletally mature patients.

This system is supplied as a reusable surgical implant, available in multiple size configurations to accommodate varying patient anatomies. It is intended for use in the lumbar spine (L2–S1) and has received FDA 510(k) clearance under the Traditional pathway, along with MDR authorization. Sterility and MRI safety are not specified in the provided data.

AI-generated from registry data, 18 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK151773 Date20 Nov 2015ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenSwedenLatviaEstoniaUnited States of AmericaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandUnited 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 AmericaFranceFranceAustriaHungaryRomaniaUnited 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 AmericaFranceFranceSloveniaBulgariaUnited 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 AmericaPortugalSpainSpainItalyUnited 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 AmericaSpainSpainCroatiaGreeceUnited 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 AmericaMaltaCyprusUnited 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
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

EUDAMED · 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

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Questions

  • What types of patients is the Concorde Bullet Lumbar Interbody System designed for?

    The Concorde Bullet Lumbar Interbody System is designed for skeletally mature patients requiring spinal stabilization and bone fusion in the lumbar spine region, specifically from L2 to S1. It is not intended for pediatric or non-skeletally mature patients.

  • Is the Concorde Bullet Lumbar Interbody System reusable or single-use, and how is it supplied?

    The Concorde Bullet Lumbar Interbody System is supplied as a reusable surgical implant. It comes in multiple size configurations to accommodate different patient anatomies, ensuring flexibility for lumbar spine procedures.

  • What materials is the Concorde Bullet Lumbar Interbody System made from, and how does this affect its use?

    The system is made from a polymer/carbon fiber composite, which provides structural integrity for spinal stabilization while promoting bone fusion. The composite material is designed to be durable for repeated use in surgical settings.

  • How was the FDA clearance for the Concorde Bullet Lumbar Interbody System determined?

    The device received FDA clearance under the Traditional 510(k) pathway, with a decision classification of Substantially Equivalent (SESE) to a predicate device. This means the FDA determined it has the same intended use and technological characteristics as a previously cleared device.

  • What regulatory pathways has the Concorde Bullet Lumbar Interbody System undergone, and what does this mean for its use?

    The system has received both FDA 510(k) clearance (under the Traditional pathway) and MDR authorization, indicating compliance with both U.S. and European Union regulatory standards. This ensures it meets safety and performance requirements for use in spinal fusion procedures.