Skip to content

AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine System, BOWTI Anterior Buttress Staple Spinal System, DISCOVERY Screw System, EXPEDIUM Anterior Spine System, FRONTIER Anterior Scoliosis System, KANEDA Anterior Scoliosis System, KANEDA SR Anterior Spinal System, M-2 Anterior Plate System, MOUNTAINEER Laminoplasty System, PROFILE Anterior Thoracolumbar Plate System, UNIVERSITY PLATE Anterior System, VIPER F2 Facet Fixation System

by Medos International SARL

510(k) K192281

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K192281↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, 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 510(k) Substantially Equivalent · Traditional NumberK192281 Date20 Nov 2019ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

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

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
MRW
Device Class
U
Advisory Committee
Unknown
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.

This system comprises spinal fixation devices designed for anterior stabilization of the spine, including plates, screws, buttress staples, and interbody fusion components. The devices are categorized as facet screw spinal devices and are intended for use in surgical approaches such as lateral, anterolateral, or anterior, depending on the specific system. They provide structural support to the lumbar, thoracolumbar, or cervical spine regions, often in conjunction with allografts or interbody fusion devices to enhance biomechanical stability during spinal fusion procedures.

The devices are supplied sterile and intended for single-use, with each system featuring distinct hardware tailored for specific spinal segments. They are regulated under FDA 510(k) clearance and EU MDR compliance, with model-specific FEI numbers for traceability. Systems are designed for use in operating rooms, with sterilization and storage adhering to medical device protocols. No MRI safety information is provided, and sizes vary by system to accommodate anatomical differences.

Other devices from Medos International SARL

See all devices from Medos International SARL →

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 are the MEDOS Anterior Spine Systems designed for?

    The MEDOS Anterior Spine Systems are designed for anterior stabilization of the spine, providing structural support during spinal fusion procedures. They are intended for use in the lumbar, thoracolumbar, or cervical spine regions and are often combined with allografts or interbody fusion devices to enhance biomechanical stability. These systems are tailored for specific surgical approaches, including lateral, anterolateral, or anterior, depending on the system.

  • Are the MEDOS Anterior Spine Systems sterile and single-use?

    Yes, the MEDOS Anterior Spine Systems are supplied sterile and intended for single-use only. This ensures patient safety and reduces the risk of infection or cross-contamination, adhering to standard medical device protocols for sterile surgical instrumentation.

  • How are the systems regulated and what does this mean for clinicians?

    The MEDOS Anterior Spine Systems are regulated under FDA 510(k) clearance and comply with EU MDR (Medical Device Regulation). This means the devices have undergone rigorous evaluation to demonstrate substantial equivalence to legally marketed predicate devices, ensuring they meet safety and performance standards for clinical use in the U.S. and EU markets.

  • Do the systems come in different sizes, and how are they tailored to patients?

    Yes, the MEDOS Anterior Spine Systems are designed with varying sizes to accommodate anatomical differences across patients. Each system features distinct hardware tailored for specific spinal segments, allowing clinicians to select the appropriate components for optimal fit and stability during surgical procedures.

  • What storage and handling instructions should be followed for these systems?

    The MEDOS Anterior Spine Systems must be stored and handled according to standard medical device protocols to maintain sterility. They should be kept in their original packaging until ready for use, protected from contamination, and stored in a clean, dry environment. Follow manufacturer guidelines for unpacking and preparation in the operating room to ensure proper handling.