ClearanceBrief
510(k) K191247 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

SmartSPACE Shoulder System

ApplicantTechmah Medical, LLC, Knoxville TN, US
DecisionSubstantially Equivalent, Nov 15, 2019
ReceivedMay 9, 2019
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K191247

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.