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FDA 510(k)

EZ-TRAXTM Persona Knee Containment Device

K-Number: K211007 · 2021-07-01

ApplicantK1 Medical, LLC
Decision Date2021-07-01
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

EZ-TRAXTM Persona Knee Containment Device is a medical device manufactured by K1 Medical, LLC. It received FDA 510(k) clearance on 2021-07-01 under approval number K211007. 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-TRAXTM Persona Knee Containment Device?

EZ-TRAXTM Persona Knee Containment Device is a medical device that received FDA 510(k) clearance on 2021-07-01. It is manufactured by K1 Medical, LLC. The 510(k) number is K211007.

When was EZ-TRAXTM Persona Knee Containment Device approved by the FDA?

EZ-TRAXTM Persona Knee Containment Device received FDA 510(k) clearance on 2021-07-01, under approval number K211007.

What company makes EZ-TRAXTM Persona Knee Containment Device?

EZ-TRAXTM Persona Knee Containment Device is manufactured by K1 Medical, LLC.

What is the FDA product code for EZ-TRAXTM Persona Knee Containment Device?

The FDA product code for EZ-TRAXTM Persona Knee Containment Device is KCT.

Other Devices by K1 Medical, LLC

K192487EZ-TRAX Containment Device K202270EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device K213209EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device

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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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