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EAGLE Plus Anterior Cervical Plate System, EAGLE Plus Micro Anterior Cervical Plate System, PULSE Anterior Cervical Plate System, SKYLINE Anterior Cervical Plate System, SLIM LOC Anterior Cervical Plate System, SWIFT Plus Anterior Cervical Plate System, UNIPLATE Anterior Cervical Plate System, UNIPLATE 2 Anterior Cervical Plate System

by Medos International SARL

510(k) K171439

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) K171439↗

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 NumberK171439 Date20 Jul 2017ClearedStatusActive
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  • Withdrawn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
KWQ
Device Class
Class II
Regulation
21 CFR Part 888.3060
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 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 Eagle Plus Anterior Cervical Plate System is a class of orthopedic fixation devices designed for internal stabilization of the cervical spine. These systems include plates and screws configured for anterior cervical fusion, providing rigid support to maintain proper alignment and promote bony union in cervical vertebrae.

The systems are supplied sterile and intended for single-use, with components available in various sizes to accommodate different anatomical requirements. Each system is approved under FDA 510K and MDR, ensuring compliance with regulatory standards for orthopedic spinal fixation. Devices are intended for use in operating rooms by trained surgeons and must be stored according to manufacturer instructions to preserve sterility.

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Questions

AI-generated answers, 18 Sep 2026

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

  • Are these anterior cervical plate systems designed for reuse in multiple patients, or are they intended for single-use only?

    These systems are explicitly intended for single-use only, as stated in the manufacturer’s instructions. The components are supplied sterile and must remain unopened until use to maintain sterility, ensuring compliance with surgical best practices for spinal fixation.

  • What regulatory pathways have these devices undergone to ensure their safety and effectiveness?

    The systems are approved under FDA 510K (traditional clearance via the Orthopedic Advisory Committee) and MDR (Medical Device Regulation). This means they meet U.S. and EU regulatory standards for orthopedic spinal fixation, ensuring compliance with rigorous pre-market evaluations.

  • How should these plates be stored to preserve their sterility before use?

    The manufacturer instructs that these devices must be stored according to their provided guidelines to maintain sterility. Since they are supplied sterile and single-use, they should remain in their original packaging until opened in the operating room, avoiding exposure to contaminants.

  • Do these systems come in multiple sizes, and if so, how does that accommodate different patient anatomies?

    Yes, the systems include various sizes to match different anatomical requirements for cervical spine fixation. The configurations allow surgeons to select the appropriate plate and screw lengths for optimal alignment and bony union in procedures like anterior cervical fusion.