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FDA 510(k)

Huvex Interspinous Fusion System

K-Number: K223790 · 2023-03-09

ApplicantDio Medical Corp.
Decision Date2023-03-09
Product CodePEK
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Huvex Interspinous Fusion System is a medical device manufactured by Dio Medical Corp.. It received FDA 510(k) clearance on 2023-03-09 under approval number K223790. 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 Fusion System?

Huvex Interspinous Fusion System is a medical device that received FDA 510(k) clearance on 2023-03-09. It is manufactured by Dio Medical Corp.. The 510(k) number is K223790.

When was Huvex Interspinous Fusion System approved by the FDA?

Huvex Interspinous Fusion System received FDA 510(k) clearance on 2023-03-09, under approval number K223790.

What company makes Huvex Interspinous Fusion System?

Huvex Interspinous Fusion System is manufactured by Dio Medical Corp..

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

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

Related Clinical Trials

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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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