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X-Mesh

FDA UDI

Class II (US FDA UDI)

by Medos International Sàrl

Identity

Trade Name
X-MESH FDA UDI
Generic Name
Metallic spinal interbody fusion cage FDA UDI
Device Name
X-MESH EXPANDABLE CAGE SYSTEM EXPANDABLE VERTEBRAL BODY REPLACEMENT, LATERAL, SMALL 33 - 46mm, 0/0 DEGREES FDA UDI
Model / Reference
188900033 FDA UDI
Description
X-MESH EXPANDABLE CAGE SYSTEM EXPANDABLE VERTEBRAL BODY REPLACEMENT, LATERAL, SMALL 33 - 46mm, 0/0 DEGREES FDA UDI

Identifiers

Catalog Number
188900033 FDA UDI
Primary DI / UDI-DI
10705034159522 FDA UDI
510(k) Number
K080568 FDA UDI
K173787 FDA UDI
FDA Product Code
MQP FDA UDI
GMDN Term
Metallic spinal interbody fusion cage FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3060 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

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

Cleared under the same submission

K173787 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medos International Sàrl

Sources (1)

  • FDA UDI 9157835b-7236-4995-82f9-8b6b4ed3d7e5 37 fields · synced May 31, 2026