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FDA 510(k)

Avinent Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes

K-Number: K201533 · 2021-03-01

ApplicantAvinent Implant System S.L.U.
Decision Date2021-03-01
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Avinent Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes is a medical device manufactured by Avinent Implant System S.L.U.. It received FDA 510(k) clearance on 2021-03-01 under approval number K201533. 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 Avinent Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes?

Avinent Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes is a medical device that received FDA 510(k) clearance on 2021-03-01. It is manufactured by Avinent Implant System S.L.U.. The 510(k) number is K201533.

When was Avinent Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes approved by the FDA?

Avinent Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes received FDA 510(k) clearance on 2021-03-01, under approval number K201533.

What company makes Avinent Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes?

Avinent Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes is manufactured by Avinent Implant System S.L.U..

What is the FDA product code for Avinent Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes?

The FDA product code for Avinent Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes is KCT.

Other Devices by Avinent Implant System S.L.U.

K191566Avinent Surgical Tray

Related Devices (Code: KCT)

K160574K3PRO SURGICAL TRAYArgon Med. Productions Vertriebs Gesellschaft Mbh CO KG K162600Jewel Precision Reusable Rigid Sterilization Container SystemJewel Precision Sheet Metal & Machine, Inc. K160912Sterilization TraySTERIS Corporation K161347Signia sterilization trayCovidien K152745ReNew Sterilization Trays(Catalog #3708 and #3709)Microline Surgical, Inc. K152111Symmetry Surgical Quad-Lock Container SystemSymmetry Surgical, Inc.

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.

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