510(k) Report

Devices descending from K230840

9 later devices reach PMT Facet Fixation System, Lumbar (PMT FFS-LX) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K261209Ion-LSurGenTec, LLC20260—
+1K253190CORUS-LX ImplantProvidence Medical Technology, Inc.20250—
+1K252153FFX Facet Fixation SystemSc Medica20252—
+1K251885CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX ImplantProvidence Medical Technology, Inc.20251—
+1K232468SC Medica FFXSc Medica20243—
+1K240085zLOCK Lumbar Facet Fixation SystemZygofix, Ltd.20242—
+2K250679FFX Facet Fixation SystemSc Medica20250—
+2K242527The Karma® Fixation SystemSpinal Elements, Inc.20250—
+2K242650zLOCK Lumbar Facet Fixation SystemZygofix, Ltd.20240—