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Mountaineer Oct Spinal System

by Medos International SARL EUDAMEDGUDID

Active European Union

Ref 188362045S, 188364200, 188364100, 188311201Model ‌MOUNTAINEER OCT SYSTEM OC PLATES, ‌MOUNTAINEER OCT SYSTEM OC RODS, ‌MOUNTAINEER OCT SYSTEM CONNECTORS

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0705034a002415U Basic UDI-DIDate17 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number10705034422268 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  • Withdrawn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

0 recalls · FDA

No FDA recalls on record, checked 24 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Mountaineer Oct Spinal System EUDAMED
Mountaineer GUDID
Generic Name
Bone-screw internal spinal fixation system connector
Device Name
‌plates for Cervical Fixation System
‌rods for Cervical Fixation System
‌connectors for Cervical Fixation System
Model / Ref / Catalog
‌MOUNTAINEER OCT SYSTEM OC PLATES, 188362045S, ‌MOUNTAINEER OCT SYSTEM OC RODS, 188364200, 188364100, ‌MOUNTAINEER OCT SYSTEM CONNECTORS, 188311201
Primary DI / UDI-DI
10705034422268, 10705034159065, 10705034159041, 10705034156712
Basic UDI-DI
0705034a002415U, 0705034a002435Y, 0705034a0024462
510(k) Number
FDA Product Code
NKG, MNI, KWP
EMDN Code
P09070301 Cervical fixation systems
GMDN Term
Bone-screw internal spinal fixation system connector
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
888.3075, 888.3070, 888.3050
Market of Registration
Belgium
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II
SterileEUDAMED
Yes
No
GUDID
No

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

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

Other properties (19)

  • 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