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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 a medical device manufactured by Dio Medical Co., Ltd.. It received FDA 510(k) clearance on 2016-11-21 under approval 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. It is manufactured by Dio Medical Co., Ltd.. The 510(k) number is K162220.

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

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

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

DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) Cage is manufactured by Dio Medical Co., Ltd..

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.

Other Devices by Dio Medical Co., Ltd.

K162849Huvex Interspinous Fixation System

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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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