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Endo-Model Standard Knee Prosthesis System

FDA UDI

Class II (US FDA UDI)

by WALDEMAR LINK GmbH & Co. KG

Identity

Trade Name
Endo-Model Standard Knee Prosthesis System FDA UDI
Generic Name
Rotating hinged total knee prosthesis FDA UDI
Device Name
Rotational Knee Joint Prosthesis,with anti-luxation device FDA UDI
Model / Reference
15-8023/24 FDA UDI
Description
Rotational Knee Joint Prosthesis,with anti-luxation device FDA UDI

Identifiers

Catalog Number
15-8023/24 FDA UDI
Primary DI / UDI-DI
04026575048021 FDA UDI
510(k) Number
K821476 FDA UDI
FDA Product Code
KRO FDA UDI
GMDN Term
Rotating hinged total knee 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

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Rotating hinged total knee prosthesis

Endo-Model Standard 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 Rotating hinged total knee prosthesis.

Cleared under the same submission

K821476 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
WALDEMAR LINK GmbH & Co. KG

Sources (1)

  • FDA UDI f454ab3a-861c-4936-a874-09e6e50efb26 35 fields · synced Jun 8, 2026