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FDA 510(k)

FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous Fixation System, and AEON-C™ Stand Alone System

K-Number: K232877 · 2023-12-13

ApplicantK&J Consulting Corporation
Decision Date2023-12-13
Product CodeMRW
DecisionSubstantially Equivalent

Device Summary

FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous Fixation System, and AEON-C™ Stand Alone System is a medical device manufactured by K&J Consulting Corporation. It received FDA 510(k) clearance on 2023-12-13 under approval number K232877. The device is classified under product code MRW. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous Fixation System, and AEON-C™ Stand Alone System?

FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous Fixation System, and AEON-C™ Stand Alone System is a medical device that received FDA 510(k) clearance on 2023-12-13. It is manufactured by K&J Consulting Corporation. The 510(k) number is K232877.

When was FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous Fixation System, and AEON-C™ Stand Alone System approved by the FDA?

FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous Fixation System, and AEON-C™ Stand Alone System received FDA 510(k) clearance on 2023-12-13, under approval number K232877.

What company makes FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous Fixation System, and AEON-C™ Stand Alone System?

FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous Fixation System, and AEON-C™ Stand Alone System is manufactured by K&J Consulting Corporation.

What is the FDA product code for FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous Fixation System, and AEON-C™ Stand Alone System?

The FDA product code for FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous Fixation System, and AEON-C™ Stand Alone System is MRW.

Related Clinical Trials

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Other Devices by K&J Consulting Corporation

K212038K&J IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage

Related Devices (Code: MRW)

K161798FacetBRIDGE® SystemLdr Spine USA, Inc. K152137FacetBRIDGE SystemLdr Spine USA K163374ALLY™ Facet ScrewsProvidence Medical Technology, Inc. K180729FaSet Fixation SystemHuvexel Co. , Ltd. K173198Facet Screw Fixation SystemU&I Corporation K192744CORRIDOR Fixation SystemGlobus Medical, Inc.

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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