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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 the device name listed in this FDA 510(k) record. The listed applicant is Waldemar Link GmbH & Co. KG. It received FDA 510(k) clearance on 2022-05-03 under 510(k) 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. The listed applicant is Waldemar Link GmbH & Co. KG. The 510(k) number is K220628.

When did LINK Endo-Model EVO Knee System receive FDA 510(k) clearance?

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

Who is the listed applicant for LINK Endo-Model EVO Knee System?

The FDA 510(k) record lists Waldemar Link GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Waldemar Link GmbH & Co. KG as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)K250375Allure Hip Stem and Intramedullary PlugsK243927MobileLink Acetabular Cup System - inhouse coatingsK241636MobileLink Acetabular Cup System - Line Extension (Multiple)K231445LINK Embrace Shoulder System - Reverse ConfigurationK222066LINK MobileLink Acetabular Cup System

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Related Devices (Code: KRO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker OrthopaedicsK252898Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathlon® Asymmetric Patella; Scorpio® Universal Dome Patella; Triathlon® Hinge BumperHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK252303Stem Extension Line (USTAR II System)United Orthopedic CorporationK251665Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK242871ATTUNE™ Revision Hinge KneeDepuy Ireland UCK240043EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW Modular Distal Femoral System;REPIPHYSIS™ Limb Salvage System;EVOLUTION® MP Total Knee System; EVOLUTION® MP Total Knee System; EVOLUTION® MP Adaptive CS Insert; EVOLUTION® MP Adaptive PS Tibial Insert; EVOLUTION® MP CS/CR Porous Femur/EVOLUTION® Adaptive CS and PS Inserts; EVOLUTION® Revision CCK System; ADVANCE® Double High Insert; ADVANCE® A-CLASS® Tibial Insert; ADVANCE® Knee System; ADVANCE® Ultra-Congruent Tibial InseMicroport Orthopedics, Inc.

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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