ClearanceBrief
510(k) K251735 ยท OVE Intervertebral Fusion Device With Integrated Fixation, Cervical

Stabilis SA Cervical Stand-Alone System (Various PNs)

ApplicantAcuity Surgical Devices, LLC, Irving TX, US
DecisionSubstantially Equivalent, Jul 30, 2025
ReceivedJun 6, 2025
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K251735

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.