510(k) Report

Devices descending from K000943

29 later devices reach Cemex System Gun Application Version through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K041105Macropore Hydrosorb Spine SystemMacropore Biosurgery, Inc.20044—
+1K033596Cemex Genta Bone Cement; Cemex Genta System Bone CementExactech, Inc.200416—
+1K031430Cemex System FastExactech, Inc.20030—
+1K021499Cemvac Ultra Pre-Packed with Depuy 1 Bone CementDePuy Orthopaedics, Inc.20022—
+1K021715Cemex RX, Cemex Isoplastic & Cemex XLExactech, Inc.20023—
+2K211163Bone Cement Genta, Bone Cement HV, Bone Cement LVTecres S.P.A.20230—
+2K143134NP Cement HV;NP Cement LV; NP Cement HV System; NP Cement LV SystemCossington, Ltd.20152—
+2K143100NP Cement HV Genta;NP Cement LV Genta;NP Cement HV System Genta;NP Cement LV System GentaCossington, Ltd.201512—
+2K092773Cemex Genta, Genta System and Genta System FastTecres S.P.A.200914—
+2K063461Anova Containment DeviceAnova Corporation20090—
+2K071810Inion Spinal Graft Containment SystemInion, Ltd.20081—
+2K053445Smartmix Cemvac Pre-Filled with Smartset HV Bone CementDePuy Orthopaedics, Inc.20060—
+2K051821Inion S-1 Biodegradable Anterior Cervical Fusion SystemInion, Ltd.20052—
+2K043403Cemex System Genta Fast Bone CementExactech, Inc.200415—
+2K042591Smartmix Pre-Filled Mixing SystemDePuy Orthopaedics, Inc.20041—
+3K242216Gentafix® (1, 3, 3MV)Teknimed Sas20240—
+3K210125BonOs HV Genta, BonOs MV Genta, BonOs LV GentaOsartis GmbH20210—
+3K210120BonOs HV, BonOs MV, BonOs LVOsartis GmbH20210—
+3K172906REMEDY PLUS Hip Spacer, UNITE PLUS Bone CementOsteoremedies, LLC20189—
+3K151360Inion Spinal Graft Containment SystemInion OY20150—
+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—