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Mountaineer 188311002

by Medos International Sàrl

Ref 188311002

Mountaineer 188311002 is a device classified as Class IIb in the EU and Class II in the US made by Medos International Sàrl, registered in EUDAMED on 3 Nov 2026 (Basic UDI-DI B-CHMF000014268000117YD), cleared under FDA 510(k) K190895 on 18 Jul 2019 (2 earlier submissions) and listed in FDA GUDID since 24 Sep 2015 (UDI-DI D-CHMF000014268000117YD), active as of 7 Nov 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K190895

+2 more

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-CHMF000014268000117YD Basic UDI-DI D-CHMF000014268000117YDUDI-DIDate3 Nov 2026RegisteredStatusActive
United StatesFDA 510(k) GUDID from GUDID NumberK190895 Date18 Jul 2019IssuedStatusActive
United StatesGUDID listing GUDID NumberD-CHMF000014268000117YD UDI-DI Date24 Sep 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-CHMF000014268000117YD registered 3 Nov 2026 Active
  • FDA 510(k) K190895 decided 18 Jul 2019 Active· +2 more in the status table
  • FDA GUDID UDI-DI D-CHMF000014268000117YD listed 24 Sep 2015 Listed

Timeline

5 dated events

  1. Cleared FDA 510(k) K041203
  2. Cleared FDA 510(k) K151885
  3. Listed FDA GUDID D-CHMF000014268000117YD
  4. Cleared FDA 510(k) K190895
  5. Registered EUDAMED B-CHMF000014268000117YD

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Mountaineer
Generic name
Bone-screw internal spinal fixation system rod
Model / Ref / Catalog
188311002
Primary DI / UDI-DI
D-CHMF000014268000117YD EUDAMED
10705034156552 GUDID
Basic UDI-DI
B-CHMF000014268000117YD
510(k) Number
FDA product code
NKG, MNI, KWP
EMDN code
P09070301 Cervical fixation systems
GMDN term
Bone-screw internal spinal fixation system rod
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3075, 888.3070, 888.3050
EU registration type
Legacy device (under a directive)
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
D-CHMF000014268000117YD
GUDID
10705034156552
Device classEUDAMED
Class IIb
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists D-CHMF000014268000117YD; FDA GUDID lists 10705034156552), so their flags are not compared. Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Bone-screw internal spinal fixation system rod

Cleared under the same submission (K041203)

and 1 more cleared under K041203

Cleared under the same submission (K151885)

and 1 more cleared under K151885

Similar devices in this category

Other devices filed under CERVICAL FIXATION SYSTEMS.

Other devices from Medos International SARL

See all devices from Medos International SARL →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
Other properties (20, all answered No)