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FDA 510(k)

Huvex Interspinous Fixation System

K-Number: K162849 · 2017-02-16

ApplicantDio Medical Co., Ltd.
Decision Date2017-02-16
Product CodePEK
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Huvex Interspinous Fixation System is a medical device manufactured by Dio Medical Co., Ltd.. It received FDA 510(k) clearance on 2017-02-16 under approval number K162849. The device is classified under product code PEK. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Huvex Interspinous Fixation System?

Huvex Interspinous Fixation System is a medical device that received FDA 510(k) clearance on 2017-02-16. It is manufactured by Dio Medical Co., Ltd.. The 510(k) number is K162849.

When was Huvex Interspinous Fixation System approved by the FDA?

Huvex Interspinous Fixation System received FDA 510(k) clearance on 2017-02-16, under approval number K162849.

What company makes Huvex Interspinous Fixation System?

Huvex Interspinous Fixation System is manufactured by Dio Medical Co., Ltd..

What is the FDA product code for Huvex Interspinous Fixation System?

The FDA product code for Huvex Interspinous Fixation System is PEK.

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Other Devices by Dio Medical Co., Ltd.

K162220DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) Cage

Related Devices (Code: PEK)

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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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