ClearanceBrief
510(k) K250827 · MAX Intervertebral Fusion Device With Bone Graft, Lumbar

aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion device; aprevo® anterior lumbar interbody fusion device with interfixation; aprevo® transforaminal lumbar interbody fusion device; aprevo® TLIF-CA Articulating System; aprevo® Cervical ACDF; aprevo® Cervical ACD

ApplicantCarlsmed, Inc., Carlsbad CA, US
DecisionSubstantially Equivalent, Jul 7, 2025
ReceivedMar 18, 2025
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K250827

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.