510(k) K202270

EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device by K1 Medical, LLC — Product Code KCT

K202270 is an FDA 510(k) premarket notification submitted by K1 Medical, LLC for the device "EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device". The FDA issued a decision of Substantially Equivalent on Dec 2, 2020. The device falls under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories), a Class II device regulated under 21 CFR 880.6850. K1 Medical, LLC has 3 other 510(k) clearances on record.