Mountaineer 188320420

by Medos International Sàrl

Mountaineer 188320420 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 10705034290690), 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

+2 more

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k) from GUDID	NumberK190895	Date18 Jul 2019Issued	StatusActive
United States	GUDID listing	Number10705034290690 UDI-DI	Date24 Sep 2015Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k) from GUDID	NumberK151885	Date3 Sep 2015Issued	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Special	NumberK041203	Date2 Jun 2004Decided	StatusActive

Official records

AccessGUDID record UDI-DI 10705034290690
FDA 510(k) database 510(k) number K190895
FDA 510(k) database 510(k) number K151885
FDA 510(k) database 510(k) number K041203

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 10705034290690 listed 24 Sep 2015 Listed

Timeline

4 dated events

2 Jun 2004 Cleared FDA 510(k) K041203
3 Sep 2015 Cleared FDA 510(k) K151885
24 Sep 2015 Listed FDA GUDID 10705034290690
18 Jul 2019 Cleared FDA 510(k) K190895

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Mountaineer
Generic name: Spinal bone screw, non-bioabsorbable
Model / Ref / Catalog: 188320420

Primary DI / UDI-DI: 10705034290690
510(k) Number: K041203
K151885
K190895
FDA product code: NKG, KWP, MNI
GMDN term: Spinal bone screw, non-bioabsorbable

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

Similar devices in this category

Other devices filed under Spinal bone screw, non-bioabsorbable.

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Properties

Sterilise before use
Single use
Implantable
Prescription use
Lot / batch number

Other properties (10, all answered No)