FDA 510(k)

IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF)

Número K: K173080 · 2017-10-31

Data da decisão2017-10-31

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF) is the device name listed in this FDA 510(k) record. The listed applicant is Huvexel Co. , Ltd.. It received FDA 510(k) clearance on 2017-10-31 under 510(k) number K173080. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF)?

IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF) is a medical device that received FDA 510(k) clearance on 2017-10-31. The listed applicant is Huvexel Co. , Ltd.. The 510(k) number is K173080.

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

IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF) received FDA 510(k) clearance on 2017-10-31, under 510(k) number K173080.

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

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

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

The FDA product code for IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF) is MAX.

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Fonte oficial

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