FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous Fixation System, and AEON-C Stand Alone System— 510(k) K232877

Name: FDA 510(k) clearance K232877
Creator: U.S. Food and Drug Administration
Published: 2023-12-13

Substantially Equivalent

K&J Consulting Corporation

FDA 510(k) clearance K232877 for FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous Fixation System, and AEON-C Stand Alone System, Substantially Equivalent on 2023-12-13. Applicant: K&J Consulting Corporation. Device class: Unclassified.

Clearance details

Applicant: K&J Consulting Corporation
Product code: Code MRW
Device class: Unclassified
Advisory panel: Unknown
Date received: 2023-09-15
Decision date: 2023-12-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lansdale, PA, US

Download summary PDF View on FDA.gov ↗

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