LINK Vario-Cup Prosthesis

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 107-220/63Model Bipolar head, uncemented, CoCrMo, UHMWPE

by WALDEMAR LINK GmbH & Co. KG

Identity

Trade Name: LINK Vario-Cup Prosthesis FDA UDI
Generic Name: Bipolar femoral head outer component, hemiarthroplasty FDA UDI
Device Name: Vario-Cup System EUDAMED
Vario-Head Cup,self-centering FDA UDI
Model / Reference: 107-220/63 EUDAMEDFDA UDI
Bipolar head, uncemented, CoCrMo, UHMWPE EUDAMED
Description: Vario-Head Cup,self-centering FDA UDI

Identifiers

Catalog Number: 107-220/63 FDA UDI
Primary DI / UDI-DI: 04026575329670 EUDAMEDFDA UDI
Basic UDI-DI: 4026575-1-HSP-034001-X7 EUDAMED
510(k) Number: K781735 FDA UDI
FDA Product Code: KWY FDA UDI
EMDN Code: P0908040503 HIP PROSTHESES, BI-ARTICULAR CUPS EUDAMED
GMDN Term: Bipolar femoral head outer component, hemiarthroplasty FDA UDI

Classification

Device Class: Class III EUDAMED
Class II FDA UDI
Regulation Number: 888.3390 FDA UDI
Market of Registration: Germany EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

Yes

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Bipolar femoral head outer component, hemiarthroplasty

LINK Vario-Cup Prosthesis by WALDEMAR LINK GmbH & Co. KG — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

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UHR — Howmedica Osteonics Corp. · Class II
SLR BIPOLAR — MicroPort Orthopedics Inc. · Class II
MultiPolar® — Zimmer, Inc. · Class II

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Unknown
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 (2)

FDA UDI 411b639f-0457-4158-a54d-8a85d9e880c4 35 fields · synced Oct 6, 2026
EUDAMED d38f9c25-91f3-4eab-8c1f-404e04c104fb 61 fields · synced Oct 6, 2026

LINK Vario-Cup Prosthesis

Identity

Identifiers

Classification

Clinical & Handling

Similar devices

Cleared under the same submission

Authorization Coverage (2 countries)

Regulatory Authorizations

Manufacturer

Sources (2)