FDA 510(k)

4CIS® Marlin ACIF Cage System

N.º K: K162402 · 2017-02-16

Fecha de decisión2017-02-16

Código de productoODP

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

4CIS® Marlin ACIF Cage System is the device name listed in this FDA 510(k) record. The listed applicant is Solco Biomedical Co., Ltd.. It received FDA 510(k) clearance on 2017-02-16 under 510(k) number K162402. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the 4CIS® Marlin ACIF Cage System?

4CIS® Marlin ACIF Cage System is a medical device that received FDA 510(k) clearance on 2017-02-16. The listed applicant is Solco Biomedical Co., Ltd.. The 510(k) number is K162402.

When did 4CIS® Marlin ACIF Cage System receive FDA 510(k) clearance?

4CIS® Marlin ACIF Cage System received FDA 510(k) clearance on 2017-02-16, under 510(k) number K162402.

Who is the listed applicant for 4CIS® Marlin ACIF Cage System?

The FDA 510(k) record lists Solco Biomedical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 4CIS® Marlin ACIF Cage System?

The FDA product code for 4CIS® Marlin ACIF Cage System is ODP.

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Otros registros que enlistan a Solco Biomedical Co., Ltd. como solicitante

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Fuente oficial

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