Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device

K-Number: K202270 · 2020-12-02

ApplicantK1 Medical, LLC
Decision Date2020-12-02
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device is the device name listed in this FDA 510(k) record. The listed applicant is K1 Medical, LLC. It received FDA 510(k) clearance on 2020-12-02 under 510(k) 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. The listed applicant is K1 Medical, LLC. The 510(k) number is K202270.

When did EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device receive FDA 510(k) clearance?

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

Who is the listed applicant for EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device?

The FDA 510(k) record lists K1 Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing K1 Medical, LLC 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.

K213209EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment DeviceK211007EZ-TRAXTM Persona Knee Containment DeviceK192487EZ-TRAX Containment Device

Related Devices (Code: KCT)

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.

K253187SteriBest® Sterilization Tray SystemMastel SurgicalK260726Straumann® ProClean™ Cassette (041.800 ; 041.801)Institut Straumann AGK252854SteriTite Container System with MediTray ProductsCase Medical, Inc.K253791PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System LidDePuy Mitek, Inc.K251614Stainless Steel Surgical KitsDentsply Sirona, Inc.K251756Sterilization TraysParagon Implant Mfg., LLC

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.

↑