FDA 510(k)

Avinent Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes

N.º K: K201533 · 2021-03-01

SolicitanteAvinent Implant System S.L.U.

Fecha de decisión2021-03-01

Código de productoKCT

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Avinent Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes is the device name listed in this FDA 510(k) record. The listed applicant is Avinent Implant System S.L.U.. It received FDA 510(k) clearance on 2021-03-01 under 510(k) number K201533. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

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. The listed applicant is Avinent Implant System S.L.U.. The 510(k) number is K201533.

When did Avinent Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes receive FDA 510(k) clearance?

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

Who is the listed applicant for Avinent Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes?

The FDA 510(k) record lists Avinent Implant System S.L.U. as the applicant. This does not by itself establish the device manufacturer.

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.

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Otros registros que enlistan a Avinent Implant System S.L.U. como solicitante

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Dispositivos relacionados (Código: KCT)

K253988LiteSet TraysNobel Biocare AB K261935Surgical and Prosthetic TraysDentsply Sirona, Inc.K253187SteriBest® Sterilization Tray SystemMastel Surgical K252854SteriTite Container System with MediTray ProductsCase Medical, Inc.K260726Straumann® ProClean™ Cassette (041.800 ; 041.801)Institut Straumann AG K253791PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System LidDePuy Mitek, Inc.

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.