Endo-Model Modular Knee Prosthesis System

FDA UDI

Class II (US FDA UDI)

by WALDEMAR LINK GmbH & Co. KG

Identity

Trade Name: Endo-Model Modular Knee Prosthesis System FDA UDI
Generic Name: Knee femur stem prosthesis FDA UDI
Device Name: Modular Stem FDA UDI
Model / Reference: 15-3950/06 FDA UDI
Description: Modular Stem FDA UDI

Identifiers

Catalog Number: 15-3950/06 FDA UDI
Primary DI / UDI-DI: 04026575431687 FDA UDI
510(k) Number: K152431 FDA UDI
K212742 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

Yes

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

Yes

FDA UDI

Category: Knee femur stem prosthesis

Endo-Model Modular Knee Prosthesis 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.

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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

K152431 also covers:

K212742 also covers:

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 a2e07a81-6185-4c8b-991d-d4440adbf5d7 35 fields · synced Jun 8, 2026