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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
Implantable orthopaedic/craniofacial device connection screw FDA UDI
Model / Reference
15-0037/30 FDA UDI

Identifiers

Primary DI / UDI-DI
04026575302260 FDA UDI
510(k) Number
K220628 FDA UDI
FDA Product Code
KRO FDA UDI
GMDN Term
Implantable orthopaedic/craniofacial device connection screw 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

No

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Implantable orthopaedic/craniofacial device connection screw

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 Implantable orthopaedic/craniofacial device connection screw.

Cleared under the same submission

K220628 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 348c4b42-680d-4380-8163-be557c879cf4 33 fields · synced May 30, 2026