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FDA 510(k)

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

K-Number: K173080 · 2017-10-31

ApplicantHuvexel Co. , Ltd.
Decision Date2017-10-31
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Huvexel Co. , Ltd.. The 510(k) number is K173080.

When was IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF) approved by the FDA?

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

What company makes IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF)?

IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF) is manufactured by Huvexel Co. , Ltd..

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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Official Source

View on FDA Database →

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

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