ClearanceBrief
510(k) K251780 ยท OLO Orthopedic Stereotaxic Instrument

iGPS Navigation Instruments

ApplicantSI-BONE, Inc., Santa Clara CA, US
DecisionSubstantially Equivalent, Sep 15, 2025
ReceivedJun 10, 2025
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K251780

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.