510(k) Report

Devices descending from K132126

11 later devices reach Spectrum Spine Fenestrated Facet Screw System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211855Ion Facet Screw SystemSurGenTec, LLC202210—
+2K251714Ion-CSurGenTec, LLC20260—
+2K243865AERO MIS Facet Fusion SystemAurora Spine20250—
+2K243265Ion 3DSurGenTec, LLC20241—
+2K232468SC Medica FFXSc Medica20243—
+2K240086Ion 3DSurGenTec, LLC20243—
+2K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+3K252153FFX Facet Fixation SystemSc Medica20252—
+3K241416Ion 3DSurGenTec, LLC20242—
+4K261209Ion-LSurGenTec, LLC20260—
+4K250679FFX Facet Fixation SystemSc Medica20250—