Auxano® Wedge Fixation System— 510(k) K251791

Name: FDA 510(k) clearance K251791
Creator: U.S. Food and Drug Administration
Published: 2025-09-25

Substantially Equivalent

Auxano Medical, LLC

FDA 510(k) clearance K251791 for Auxano® Wedge Fixation System, Substantially Equivalent on 2025-09-25. Applicant: Auxano Medical, LLC. Device class: 2.

Clearance details

Applicant: Auxano Medical, LLC
Product code: Code PLF
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2025-06-11
Decision date: 2025-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brecksville, OH, US

Download summary PDF View on FDA.gov ↗

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