MobileLink Acetabular Cup System

FDA UDI

Class II (US FDA UDI)

by WALDEMAR LINK GmbH & Co. KG

Identity

Trade Name: MobileLink Acetabular Cup System FDA UDI
Generic Name: Non-constrained polyethylene acetabular liner FDA UDI
Device Name: UHMWPE Inserts -X-LINKed; Standard (Neutral) FDA UDI
Model / Reference: 183-352/36 FDA UDI
Description: UHMWPE Inserts -X-LINKed; Standard (Neutral) FDA UDI

Identifiers

Catalog Number: 183-352/36 FDA UDI
Primary DI / UDI-DI: 04026575177653 FDA UDI
510(k) Number: K241636 FDA UDI
FDA Product Code: MEH FDA UDI
LPH FDA UDI
LZO FDA UDI
GMDN Term: Non-constrained polyethylene acetabular liner FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3353 FDA UDI
888.3358 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Non-constrained polyethylene acetabular liner

MobileLink Acetabular Cup System by WALDEMAR LINK GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: WALDEMAR LINK GmbH & Co. KG

Sources (1)

FDA UDI d1eb7433-8197-4fd5-980e-afc066742b4c 35 fields · synced May 30, 2026

MobileLink Acetabular Cup System

Identity

Identifiers

Classification

Clinical & Handling

Similar devices

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

Manufacturer

Sources (1)