FDA 510(k)

DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) Cage

N.º K: K162220 · 2016-11-21

Fecha de decisión2016-11-21

Código de productoODP

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) Cage is the device name listed in this FDA 510(k) record. The listed applicant is Dio Medical Co., Ltd.. It received FDA 510(k) clearance on 2016-11-21 under 510(k) number K162220. 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 DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) Cage?

DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) Cage is a medical device that received FDA 510(k) clearance on 2016-11-21. The listed applicant is Dio Medical Co., Ltd.. The 510(k) number is K162220.

When did DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) Cage receive FDA 510(k) clearance?

DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) Cage received FDA 510(k) clearance on 2016-11-21, under 510(k) number K162220.

Who is the listed applicant for DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) Cage?

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

What is the FDA product code for DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) Cage?

The FDA product code for DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) Cage is ODP.

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Otros registros que enlistan a Dio Medical Co., Ltd. como solicitante

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Fuente oficial

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