510(k) K201533

Avinent Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes by Avinent Implant System S.L.U. — Product Code KCT

K201533 is an FDA 510(k) premarket notification submitted by Avinent Implant System S.L.U. for the device "Avinent Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes". The FDA issued a decision of Substantially Equivalent on March 1, 2021. The device falls under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories), a Class II device regulated under 21 CFR 880.6850. Avinent Implant System S.L.U. has at least 2 other 510(k) clearances on record.