LINK Endo-Model EVO Knee System

by WALDEMAR LINK GmbH & Co. KG

510(k) K220628

LINK Endo-Model EVO Knee System is a Class II device made by WALDEMAR LINK GmbH & Co. KG, cleared under FDA 510(k) K220628 on 3 May 2022, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K220628↗

FDA record

Trust

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK220628	Date3 May 2022Cleared	StatusActive

Official records

FDA 510(k) database 510(k) number K220628

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K220628
FDA product code: KRO

Device class: Class II
Regulation: 21 CFR Part 888.3510
Advisory committee: Orthopedic
FDA decision: SESE Substantially Equivalent

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