ClearanceBrief
510(k) K251791 · PLF Bone Wedge

Auxano® Wedge Fixation System

ApplicantAuxano Medical, LLC, Brecksville OH, US
DecisionSubstantially Equivalent, Sep 25, 2025
ReceivedJun 11, 2025
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K251791

No recall in the FDA data names this 510(k).

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.