Link OptiStem

FDA UDI

Class II (US FDA UDI)

by WALDEMAR LINK GmbH & Co. KG

Identity

Trade Name: Link OptiStem FDA UDI
Generic Name: Body femoral/tibial extension stem, uncoated FDA UDI
Device Name: Modular stem, cemented, CoCrMo, oval FDA UDI
Model / Reference: 17-2160/09 FDA UDI
Description: Modular stem, cemented, CoCrMo, oval FDA UDI

Identifiers

Primary DI / UDI-DI: 04026575284412 FDA UDI
510(k) Number: K220628 FDA UDI
FDA Product Code: KRO FDA UDI
GMDN Term: Body femoral/tibial extension stem, uncoated 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

FDA UDI

Category: Body femoral/tibial extension stem, uncoated

Link OptiStem by WALDEMAR LINK GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 4ead36d1-27fc-400f-bbf6-b9d52bfdf21d 34 fields · synced May 29, 2026