510(k) Report

Devices descending from K163374

18 later devices reach ALLY™ Facet Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230840PMT Facet Fixation System, Lumbar (PMT FFS-LX)Providence Medical Technology, Inc.20239—
+1K230297PMT Expandable Cage (PMT EXP)Providence Medical Technology, Inc.20230—
+1K211855Ion Facet Screw SystemSurGenTec, LLC202210—
+2K261209Ion-LSurGenTec, LLC20260—
+2K251714Ion-CSurGenTec, LLC20260—
+2K253190CORUS-LX ImplantProvidence Medical Technology, Inc.20250—
+2K252153FFX Facet Fixation SystemSc Medica20252—
+2K251885CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX ImplantProvidence Medical Technology, Inc.20251—
+2K243865AERO MIS Facet Fusion SystemAurora Spine20250—
+2K243265Ion 3DSurGenTec, LLC20241—
+2K232468SC Medica FFXSc Medica20243—
+2K240085zLOCK Lumbar Facet Fixation SystemZygofix, Ltd.20242—
+2K240086Ion 3DSurGenTec, LLC20243—
+2K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+3K250679FFX Facet Fixation SystemSc Medica20250—
+3K242527The Karma® Fixation SystemSpinal Elements, Inc.20250—
+3K242650zLOCK Lumbar Facet Fixation SystemZygofix, Ltd.20240—
+3K241416Ion 3DSurGenTec, LLC20242—