ClearanceBrief
510(k) K243469 ยท HRS Plate, Fixation, Bone

SIGNEX

ApplicantOsteonic Co., Ltd., Seoul, KR
DecisionSubstantially Equivalent, May 29, 2025
ReceivedNov 8, 2024
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K243469

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.