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 femur prosthesis, metallic FDA UDI
Device Name: Femoral component, cemented, CoCrMo, UHMWPE, standard, rotating hinge (EVO) FDA UDI
Model / Reference: 15-8324/11 FDA UDI
Description: Femoral component, cemented, CoCrMo, UHMWPE, standard, rotating hinge (EVO) FDA UDI

Identifiers

Primary DI / UDI-DI: 04026575267743 FDA UDI
510(k) Number: K220628 FDA UDI
FDA Product Code: KRO FDA UDI
GMDN Term: Uncoated knee femur prosthesis, metallic 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 femur prosthesis, metallic

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 femur prosthesis, metallic.

SIGMA — DEPUY (IRELAND) · Class II
Natural-Knee® — Zimmer, Inc. · Class II
LEGION — Smith & Nephew, Inc. · Class II
Orthopedic Salvage System (OSS™) — Biomet Orthopedics, Inc. · Class II
GMK Sphere Revision System — Medacta International · Class II
ACS® — implantcast GmbH · Class II
Balance Knee Revision System — ORTHO DEVELOPMENT CORP. · Class II
ADVANCE® — MicroPort Orthopedics Inc. · 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 5a319643-510d-4aa6-923c-60eddd736a33 34 fields · synced May 30, 2026