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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 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.

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. 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.

Other records listing Huvexel Co. , Ltd. as applicant

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Related Devices (Code: 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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