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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
Standard UHMWPE Insert - shouldered 5 mm FDA UDI
Model / Reference
183-266/32 FDA UDI
Description
Standard UHMWPE Insert - shouldered 5 mm FDA UDI

Identifiers

Catalog Number
183-266/32 FDA UDI
Primary DI / UDI-DI
04026575187836 FDA UDI
510(k) Number
K182321 FDA UDI
FDA Product Code
LZO FDA UDI
MEH FDA UDI
OQG FDA UDI
LPH 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
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

No

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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

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

Cleared under the same submission

K182321 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
WALDEMAR LINK GmbH & Co. KG

Sources (1)

  • FDA UDI 013009ea-e6dd-436f-ba06-bb6a8c7eaa02 36 fields · synced Jun 8, 2026