510(k) Report

Devices descending from K143100

12 later devices reach NP Cement HV Genta;NP Cement LV Genta;NP Cement HV System Genta;NP Cement LV… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211163Bone Cement Genta, Bone Cement HV, Bone Cement LVTecres S.P.A.20230—
+1K210125BonOs HV Genta, BonOs MV Genta, BonOs LV GentaOsartis GmbH20210—
+1K172906REMEDY PLUS Hip Spacer, UNITE PLUS Bone CementOsteoremedies, LLC20189—
+2K253675OsteoRemedies Hip Spacer SystemOsteoremedies, LLC20251—
+2K252326InterSpace GV Hip SpacerTecres S.P.A.20250—
+2K234028COPAL® exchange G hip spacer; COPAL® G+VHeraeus Medical GmbH20240—
+2K231556SPECTRUM® GV Bone CementOsteoremedies, LLC20231—
+2K192995OsteoRemedies Hip Spacer SystemOsteoremedies, LLC20202—
+2K191981REMEDY Acetabular CupOsteoremedies, LLC20194—
+3K262290REMEDY POLY+PLUS SNAP FIT Acetabular CupOsteoremedies, LLC20260—
+3K250760SPECTRUM GV Bone CementOsteoremedies, LLC20250—
+3K223441SpaceFlex Acetabular CupG21, S.R.L.20230—