LINK Endo-Model EVO Knee System

FDA UDI

Class II (US FDA UDI)

by WALDEMAR LINK GmbH & Co. KG

Identity

Trade Name: LINK Endo-Model EVO Knee System FDA UDI
Generic Name: Uncoated knee tibia/insert prosthesis FDA UDI
Device Name: Tibial component, cemented, CoCrMo, UHMWPE, standard, pure hinge (EVO) FDA UDI
Model / Reference: 15-2358/03 FDA UDI
Description: Tibial component, cemented, CoCrMo, UHMWPE, standard, pure hinge (EVO) FDA UDI

Identifiers

Primary DI / UDI-DI: 04026575268047 FDA UDI
510(k) Number: K220628 FDA UDI
FDA Product Code: KRO FDA UDI
GMDN Term: Uncoated knee tibia/insert prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3510 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Uncoated knee tibia/insert prosthesis

LINK Endo-Model EVO Knee System by WALDEMAR LINK GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Uncoated knee tibia/insert prosthesis.

Arthrex® — Arthrex, Inc. · Class II
Vanguard Complete Knee System — Biomet Orthopedics, Inc. · Class II
Arthrex® — Arthrex, Inc. · Class II
LOSPA Total Knee System — Corentec Co., Ltd · Class II
LOSPA Total Knee System — Corentec Co., Ltd · Class II
LOSPA Modular Knee System — Corentec Co., Ltd · Class II
Arthrex® — Arthrex, Inc. · Class II
LOSPA Modular Knee System — Corentec Co., Ltd · Class II

Cleared under the same submission

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 28048442-49d6-436b-b91f-0382859f9dbe 34 fields · synced May 29, 2026