FDA 510(k)

Avinent Surgical Tray

K-Number: K191566 · 2020-03-06

Decision Date2020-03-06

Product CodeKCT

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Avinent Surgical Tray is a medical device manufactured by Avinent Implant System S.L.U.. It received FDA 510(k) clearance on 2020-03-06 under approval number K191566. 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 Surgical Tray?

Avinent Surgical Tray is a medical device that received FDA 510(k) clearance on 2020-03-06. It is manufactured by Avinent Implant System S.L.U.. The 510(k) number is K191566.

When was Avinent Surgical Tray approved by the FDA?

Avinent Surgical Tray received FDA 510(k) clearance on 2020-03-06, under approval number K191566.

What company makes Avinent Surgical Tray?

Avinent Surgical Tray is manufactured by Avinent Implant System S.L.U..

What is the FDA product code for Avinent Surgical Tray?

The FDA product code for Avinent Surgical Tray is KCT.

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

K201533Avinent Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.