ATLAS Expandable Osteotomy Wedge System— 510(k) K252733

Name: FDA 510(k) clearance K252733
Creator: U.S. Food and Drug Administration
Published: 2026-02-19

Substantially Equivalent

MiRus, LLC

FDA 510(k) clearance K252733 for ATLAS Expandable Osteotomy Wedge System, Substantially Equivalent on 2026-02-19. Applicant: MiRus, LLC. Device class: 2.

Clearance details

Applicant: MiRus, LLC
Product code: Code PLF
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2025-08-28
Decision date: 2026-02-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marietta, GA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.