ClearanceBrief
510(k) K210837 ยท HRS Plate, Fixation, Bone

Smith & Nephew Plates and Screws

ApplicantSmith & Nephew, Inc., Memphis TN, US
DecisionSubstantially Equivalent, Jun 29, 2021
ReceivedMar 22, 2021
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K210837

DateFirm and productCodeLinked 510(k)
Oct 30, 2026Smith & Nephew, Inc.
EVOS 3.5MM LATERAL PROXIMAL TIBIA PLATE 6 HOLE LEFT 91MM REF72463106
Open, Classified
HRSNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.