ATLAS Expandable Osteotomy Wedge System
K-Number: K252733 · 2026-02-19
ApplicantMiRus, LLC
Decision Date2026-02-19
Product CodePLF
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
ATLAS Expandable Osteotomy Wedge System is a medical device manufactured by MiRus, LLC. It received FDA 510(k) clearance on 2026-02-19 under approval number K252733. The device is classified under product code PLF. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ATLAS Expandable Osteotomy Wedge System?
ATLAS Expandable Osteotomy Wedge System is a medical device that received FDA 510(k) clearance on 2026-02-19. It is manufactured by MiRus, LLC. The 510(k) number is K252733.
When was ATLAS Expandable Osteotomy Wedge System approved by the FDA?
ATLAS Expandable Osteotomy Wedge System received FDA 510(k) clearance on 2026-02-19, under approval number K252733.
What company makes ATLAS Expandable Osteotomy Wedge System?
ATLAS Expandable Osteotomy Wedge System is manufactured by MiRus, LLC.
What is the FDA product code for ATLAS Expandable Osteotomy Wedge System?
The FDA product code for ATLAS Expandable Osteotomy Wedge System is PLF.
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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.