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Skyline Anterior Cervical Plate System

by Medos International SARL EUDAMEDGUDID

Active European Union

Ref 186852014Model SKYLINE Anterior Cervical Plate System Screws

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0705034a002225Q Basic UDI-DIDate29 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10705034134239 UDI-DIDate24 Sep 2015ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

7 recalls · FDA

  • 7 recalls, same reason

    • Terminated Z-0625-2017 FDA Class II initiated 12 Oct 2016
    • Terminated Z-0630-2017 FDA Class II initiated 12 Oct 2016
    • Terminated Z-0624-2017 FDA Class II initiated 12 Oct 2016
    • Terminated Z-0626-2017 FDA Class II initiated 12 Oct 2016
    • Terminated Z-0629-2017 FDA Class II initiated 12 Oct 2016
    • Terminated Z-0628-2017 FDA Class II initiated 12 Oct 2016
    • Terminated Z-0627-2017 FDA Class II initiated 12 Oct 2016

    SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.

Specification

EUDAMED · GUDID

Trade Name
Skyline Anterior Cervical Plate System EUDAMED
Skyline GUDID
Generic Name
Spinal bone screw, non-bioabsorbable
Device Name
Screws
Model / Ref / Catalog
SKYLINE Anterior Cervical Plate System Screws, 186852014
Primary DI / UDI-DI
10705034134239
Basic UDI-DI
0705034a002225Q
510(k) Number
FDA Product Code
KWQ
EMDN Code
P09070301 Cervical fixation systems
GMDN Term
Spinal bone screw, non-bioabsorbable
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
888.3060
Market of Registration
Belgium
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
CH-MF-000014268
Authorised representative
DePuy Ireland UC IE-AR-000009328

Related devices

Category: Cervical spine immobilization system, single-use

Other devices from Medos International SARL

See all devices from Medos International SARL →

Properties

  • Single Use
  • Implantable
  • Sutures
  • Prescription Use
  • Lot / Batch Number

Other properties (20)

  • Sterile: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No