EZ-TRAX Stryker Mako Total Knee With Triathlon Containment Device

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

K1 Medical LLC

The following data is part of a premarket notification filed by K1 Medical Llc with the FDA for Ez-trax Stryker Mako Total Knee With Triathlon Containment Device.

Pre-market Notification Details

Device IDK202270
510k NumberK202270
Device Name:EZ-TRAX Stryker Mako Total Knee With Triathlon Containment Device
ClassificationSterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant K1 Medical LLC 56 Newton Road Woodbridge,  CT  06525
ContactJospeh Azary
CorrespondentJoseph Azary
Joseph Azary 543 Long Hill Avenue Shelton,  CT  06484
Product CodeKCT  
CFR Regulation Number880.6850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-11
Decision Date2020-12-02

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