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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 the device name listed in this FDA 510(k) record. The listed applicant is Dio Medical Corp.. It received FDA 510(k) clearance on 2023-03-09 under 510(k) 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. The listed applicant is Dio Medical Corp.. The 510(k) number is K223790.

When did Huvex Interspinous Fusion System receive FDA 510(k) clearance?

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

Who is the listed applicant for Huvex Interspinous Fusion System?

The FDA 510(k) record lists Dio Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Dio Medical Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K223140AEON-C™ Stand Alone SystemK222415Rexious Spinal Fixation SystemK222572FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and BALTEUM™ & BALTEUM-ONE™ Lumbar Plate SystemK222448UNITY Sacroiliac Joint Fixation SystemK222515FaSet Fixation SystemK162849Huvex Interspinous Fixation System

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Related Devices (Code: PEK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253250Minuteman® G6 MIS Fusion PlateSpinal Simplicity, LLCK234051Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3Spinal Simplicity, LLCK233527Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3 MIS Fusion PlateSpinal Simplicity, LLCK232484KeyLift™ Expandable Interlaminar Stabilization SystemFlospineK231807primaLOK™ SP Interspinous Fusion SystemWenzel Spine, Inc.K221023Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman G3/HA Minuteman G3, HA Minuteman G3-R, Minuteman G5Spinal Simplicity, LLC

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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