ClearanceBrief
510(k) K191002 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

OR3O Dual Mobility System

ApplicantSmith & Nephew, Inc., Cordova TN, US
DecisionSubstantially Equivalent, Oct 31, 2019
ReceivedApr 16, 2019
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K191002

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.