← Back to catalogue

Mountaineer

FDA UDI

Class II (US FDA UDI)

by Medos International Sàrl

Identity

Trade Name
MOUNTAINEER FDA UDI
Generic Name
Bone-screw internal spinal fixation system rod FDA UDI
Device Name
MOUNTAINEER OCT SPINAL SYSTEM DUAL DIAMETER ROD 3.5mm - 5.5mm x 600mm FDA UDI
Model / Reference
188310012 FDA UDI
Description
MOUNTAINEER OCT SPINAL SYSTEM DUAL DIAMETER ROD 3.5mm - 5.5mm x 600mm FDA UDI

Identifiers

Catalog Number
188310012 FDA UDI
Primary DI / UDI-DI
10705034290331 FDA UDI
510(k) Number
K110353 FDA UDI
K151885 FDA UDI
K190895 FDA UDI
FDA Product Code
NKG FDA UDI
KWP FDA UDI
GMDN Term
Bone-screw internal spinal fixation system rod FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3075 FDA UDI
888.3050 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Mountaineer by Medos International Sàrl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K110353 also covers:

K151885 also covers:

K190895 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Medos International Sàrl

Sources (1)

  • FDA UDI 1ea29b85-fa91-4323-9a4c-202f67790775 37 fields · synced May 31, 2026