EZ-TRAXTM Persona Knee 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-traxtm Persona Knee Containment Device.

Pre-market Notification Details

Device IDK211007
510k NumberK211007
Device Name:EZ-TRAXTM Persona Knee Containment Device
ClassificationSterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant K1 Medical LLC 56 Newton Road Woodbridge,  CT  06525
ContactWalt Oko
CorrespondentWalt Oko
K1 Medical LLC 56 Newton Road Woodbridge,  CT  06525
Product CodeKCT  
CFR Regulation Number880.6850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-02
Decision Date2021-07-01

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