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Mountaineer 188316300

by Medos International Sàrl

Ref 188319350

Active European Union. Also listed in GUDID (US), not in commercial distribution.

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 7 Nov 2026. What this means

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-CHMF000014268000179Z3 Basic UDI-DI D-CHMF000014268000179Z3UDI-DIDate3 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberD-CHMF000014268000179Z3 UDI-DI Date24 Sep 2015ListedStatusListed GUDID: not in commercial distribution

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 found in the data synced 7 Nov 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
Mountaineer
Generic Name
Bone-screw internal spinal fixation system rod
Model / Ref / Catalog
188319350, 188316300
Primary DI / UDI-DI
D-CHMF000014268000179Z3 EUDAMED
10705034157092 GUDID
Basic UDI-DI
B-CHMF000014268000179Z3
510(k) Number
FDA Product Code
NKG, KWP, MNI
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, 888.3050, 888.3070
EU market of registration
Belgium
GUDID distribution status
Not in Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
188319350
GUDID
188316300
Primary DI / UDI-DIEUDAMED
D-CHMF000014268000179Z3
GUDID
10705034157092
Device ClassEUDAMED
Class IIb
GUDID
Class II

Related devices

Cleared under the same submission (K041203)

Cleared under the same submission (K151885)

Cleared under the same submission (K190895)

Other devices from Medos International SARL

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Properties

  • Single Use
  • Implantable
  • 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