FDA 510(k)

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

Número K: K232877 · 2023-12-13

Data da decisão2023-12-13

Código do produtoMRW

DecisãoSubstantially Equivalent

Resumo do dispositivo

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

Perguntas frequentes

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. The listed applicant is K&J Consulting Corporation. The 510(k) number is K232877.

When did FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous Fixation System, and AEON-C™ Stand Alone System receive FDA 510(k) clearance?

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 510(k) number K232877.

Who is the listed applicant for FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous Fixation System, and AEON-C™ Stand Alone System?

The FDA 510(k) record lists K&J Consulting Corporation as the applicant. This does not by itself establish the device manufacturer.

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.

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