ClearanceBrief
510(k) K251441 ยท JEY Plate, Bone

Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System

ApplicantInion OY, Tampere, FI
DecisionSubstantially Equivalent, Nov 7, 2025
ReceivedMay 9, 2025
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K251441

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.