FDA 510(k)

EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device

K-Number: K202270 · 2020-12-02

Decision Date2020-12-02

Product CodeKCT

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device is a medical device manufactured by K1 Medical, LLC. It received FDA 510(k) clearance on 2020-12-02 under approval number K202270. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device?

EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device is a medical device that received FDA 510(k) clearance on 2020-12-02. It is manufactured by K1 Medical, LLC. The 510(k) number is K202270.

When was EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device approved by the FDA?

EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device received FDA 510(k) clearance on 2020-12-02, under approval number K202270.

What company makes EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device?

EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device is manufactured by K1 Medical, LLC.

What is the FDA product code for EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device?

The FDA product code for EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device is KCT.

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Related PubMed Literature

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Other Devices by K1 Medical, LLC

K192487EZ-TRAX Containment Device K213209EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device K211007EZ-TRAXTM Persona Knee Containment Device

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Official Source

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