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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 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 2017-02-16 under 510(k) 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. The listed applicant is Dio Medical Co., Ltd.. The 510(k) number is K162849.

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

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

Who is the listed applicant for Huvex Interspinous Fixation System?

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 Huvex Interspinous Fixation System?

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

Other records listing Dio Medical Co., Ltd. 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.

K223790Huvex Interspinous Fusion SystemK223140AEON-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 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.K223790Huvex Interspinous Fusion SystemDio Medical Corp.

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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