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FDA 510(k)

LINK Endo-Model EVO Knee System

K-Number: K220628 · 2022-05-03

ApplicantWaldemar Link GmbH & Co. KG
Decision Date2022-05-03
Product CodeKRO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LINK Endo-Model EVO Knee System is a medical device manufactured by Waldemar Link GmbH & Co. KG. It received FDA 510(k) clearance on 2022-05-03 under approval number K220628. The device is classified under product code KRO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LINK Endo-Model EVO Knee System?

LINK Endo-Model EVO Knee System is a medical device that received FDA 510(k) clearance on 2022-05-03. It is manufactured by Waldemar Link GmbH & Co. KG. The 510(k) number is K220628.

When was LINK Endo-Model EVO Knee System approved by the FDA?

LINK Endo-Model EVO Knee System received FDA 510(k) clearance on 2022-05-03, under approval number K220628.

What company makes LINK Endo-Model EVO Knee System?

LINK Endo-Model EVO Knee System is manufactured by Waldemar Link GmbH & Co. KG.

What is the FDA product code for LINK Endo-Model EVO Knee System?

The FDA product code for LINK Endo-Model EVO Knee System is KRO.

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Other Devices by Waldemar Link GmbH & Co. KG

K152431LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx (TiNbN) coating K161840LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip System PoroLink® (microporous) and HX® (CaP) coated K171273LINK® BiMobile(TM) Dual Mobility System K192559Acetabular Bone Screws (for MobileLink Acetabular Cup System) K190535BiMobile Dual Mobility System - E-Dur Inserts K191755SPAR-K Instruments (for use with Gemini SL Total Knee System)

View all 29 devices →

Related Devices (Code: KRO)

K163311GMK Revision Femoral Distal AugmentationMedacta International S.A. K161520ELEOS Limb Salvage SystemOnkos Surgical, Inc. K152431LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx (TiNbN) coatingWaldemar Link GmbH & Co. KG K172347GMK Hinge, GMK RevisionMedacta International S.A. K190181Instruments for LINK MEGASYSTEM-C FamilyLinkBio Corp. K191779Attune Revision LPS InsertsDepuy(Ireland)

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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