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FDA 510(k)

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

K-Number: K162220 · 2016-11-21

ApplicantDio Medical Co., Ltd.
Decision Date2016-11-21
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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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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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