510(k) Report

Devices descending from K051123

9 later devices reach Callos Impact and Inject Bone Void Filler through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200752DB-OrthopedicsDimensional Bioceramics, LLC20200—
+1K132211Skaffold NMX Bone Void FillerSkeletal Kinetics, LLC20141—
+1K112383Callos Promodel Bone Void Filler, Skaffold MP (Macro Porous) Bone Void FillerSkeletal Kinetics, LLC201213
+1K100986Callos Bone Void Filler, Skaffold Next Generation Bone Void Filler, Osteo VationSkeletal Kinetics, LLC2010011
+1K051784Osteovation CMF Bone Void FillerSkeletal Kinetics, LLC2005213
+2K212353DB-EZ Bone Void FillerDimensional Bioceramics, LLC20210—
+2K210193DB-CompositeDimensional Bioceramics, LLC20210—
+2K162864OsteoVation ImpactSkeletal Kinetics, LLC201717
+3K182742DB-CMFDimensional Bioceramics, LLC20190—