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: Knee femur stem prosthesis FDA UDI
Device Name: Modular stem, uncemented, Ti6Al4V, cylindrical (EVO) FDA UDI
Model / Reference: 15-2951/77 FDA UDI
Description: Modular stem, uncemented, Ti6Al4V, cylindrical (EVO) FDA UDI

Identifiers

Primary DI / UDI-DI: 04026575267309 FDA UDI
510(k) Number: K220628 FDA UDI
FDA Product Code: KRO FDA UDI
GMDN Term: Knee femur stem 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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Knee femur stem 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 Knee femur stem prosthesis.

Biomet Knee System — Biomet Orthopedics, Inc. · Class II
Unity Total Knee System — CORIN LTD · Class II
OPTILOCK PERIARTICULAR PLATING SYSTEM — Biomet Orthopedics, Inc. · Class II
Evolution Revision CCK System — MicroPort Orthopedics Inc. · Class II
Finn® Knee System — Biomet Orthopedics, Inc. · Class II
OSS™ Orthopedic Salvage System — Biomet Orthopedics, Inc. · Class II
Biomet® Knee System — Biomet Orthopedics, Inc. · Class II
Triathlon — Howmedica Osteonics Corp. · 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: WALDEMAR LINK GmbH & Co. KG

Sources (1)

FDA UDI a1beee78-b50e-4bec-bbb0-80de4a701568 34 fields · synced May 30, 2026