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Mountaineer 188311022

by Medos International Sàrl

Mountaineer 188311022 is a Class II device made by Medos International Sàrl, cleared under FDA 510(k) K190895 on 18 Jul 2019 (2 earlier submissions) and listed in FDA GUDID since 24 Sep 2015 (UDI-DI 10705034466385), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k) from GUDID NumberK190895 Date18 Jul 2019IssuedStatusActive
United StatesGUDID listing Number10705034466385 UDI-DI Date24 Sep 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K190895 decided 18 Jul 2019 Active· +2 more in the status table
  • FDA GUDID UDI-DI 10705034466385 listed 24 Sep 2015 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K041203
  2. Cleared FDA 510(k) K151885
  3. Listed FDA GUDID 10705034466385
  4. Cleared FDA 510(k) K190895

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Mountaineer
Generic name
Bone-screw internal spinal fixation system rod
Model / Ref / Catalog
188311022
Primary DI / UDI-DI
10705034466385
510(k) Number
FDA product code
NKG, KWP, MNI
GMDN term
Bone-screw internal spinal fixation system rod
Device class
Class II
Regulation number
888.3075, 888.3050, 888.3070
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

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)

Similar devices

Other devices filed under FDA product code NKG (Orthosis, cervical pedicle screw spinal fixation).

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 (10, all answered No)