ClearanceBrief
510(k) K250095 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue

All-Suture Dual Anchor System

ApplicantSuturetech, Inc., Durham NC, US
DecisionSubstantially Equivalent, Sep 5, 2025
ReceivedJan 14, 2025
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K250095

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.