510(k) Report

Devices descending from K043403

15 later devices reach Cemex System Genta Fast Bone Cement through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K092773Cemex Genta, Genta System and Genta System FastTecres S.P.A.200914—
+2K242216Gentafix® (1, 3, 3MV)Teknimed Sas20240—
+2K143100NP Cement HV Genta;NP Cement LV Genta;NP Cement HV System Genta;NP Cement LV System GentaCossington, Ltd.201512—
+3K211163Bone Cement Genta, Bone Cement HV, Bone Cement LVTecres S.P.A.20230—
+3K210125BonOs HV Genta, BonOs MV Genta, BonOs LV GentaOsartis GmbH20210—
+3K172906REMEDY PLUS Hip Spacer, UNITE PLUS Bone CementOsteoremedies, LLC20189—
+4K253675OsteoRemedies Hip Spacer SystemOsteoremedies, LLC20251—
+4K252326InterSpace GV Hip SpacerTecres S.P.A.20250—
+4K234028COPAL® exchange G hip spacer; COPAL® G+VHeraeus Medical GmbH20240—
+4K231556SPECTRUM® GV Bone CementOsteoremedies, LLC20231—
+4K192995OsteoRemedies Hip Spacer SystemOsteoremedies, LLC20202—
+4K191981REMEDY Acetabular CupOsteoremedies, LLC20194—
+5K262290REMEDY POLY+PLUS SNAP FIT Acetabular CupOsteoremedies, LLC20260—
+5K250760SPECTRUM GV Bone CementOsteoremedies, LLC20250—
+5K223441SpaceFlex Acetabular CupG21, S.R.L.20230—