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FDA 510(k)

UNITY Sacroiliac Joint Fixation System

K-Number: K173201 · 2018-04-26

ApplicantHuvexel Co. , Ltd.
Decision Date2018-04-26
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

UNITY Sacroiliac Joint Fixation System is a medical device manufactured by Huvexel Co. , Ltd.. It received FDA 510(k) clearance on 2018-04-26 under approval number K173201. The device is classified under product code OUR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNITY Sacroiliac Joint Fixation System?

UNITY Sacroiliac Joint Fixation System is a medical device that received FDA 510(k) clearance on 2018-04-26. It is manufactured by Huvexel Co. , Ltd.. The 510(k) number is K173201.

When was UNITY Sacroiliac Joint Fixation System approved by the FDA?

UNITY Sacroiliac Joint Fixation System received FDA 510(k) clearance on 2018-04-26, under approval number K173201.

What company makes UNITY Sacroiliac Joint Fixation System?

UNITY Sacroiliac Joint Fixation System is manufactured by Huvexel Co. , Ltd..

What is the FDA product code for UNITY Sacroiliac Joint Fixation System?

The FDA product code for UNITY Sacroiliac Joint Fixation System is OUR.

Related Clinical Trials

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Other Devices by Huvexel Co. , Ltd.

K173131Rexious Spinal Fixation System K173099Fortis and Hana Anterior Cervical Plate System K173080IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF) K180729FaSet Fixation System K191477AEON-C Stand Alone System K200846Balteum™ Lumbar Plate System

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Related Devices (Code: OUR)

K161755Integrity-SI TM Fusion SystemCoorstek Medical K153656PathLoc-SI Joint Fusion SystemL&K BIOMED Co., Ltd. K161210RIALTO(TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC(TM) Powerease(TM) System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation(TM) and IPC(TM) Powerease(TM) SystemsMedtronic Sofamor Danek K160652iFUSE Implant SystemSI-BONE, Inc. K152681iFuse Implant System(R)SI-BONE, Inc. K152237The Entasis Dual-Lead Sacroiliac ImplantCorelink, 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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