510(k) Report

Devices descending from K052043

27 later devices reach 3.8MM CS Facet Compression Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142980Proficient (TM) Facet Screw Spine SystemSpine Wave, Inc.20150—
+1K120340Venus Facet Screw SystemApollo Spine, Inc.201226—
+2K183589PMT Facet ScrewProvidence Medical Technology, Inc.20198—
+2K163374ALLY™ Facet ScrewsProvidence Medical Technology, Inc.201718—
+2K152137FacetBRIDGE SystemLdr Spine USA20161—
+3K230840PMT Facet Fixation System, Lumbar (PMT FFS-LX)Providence Medical Technology, Inc.20239—
+3K230297PMT Expandable Cage (PMT EXP)Providence Medical Technology, Inc.20230—
+3K220951PMT Facet Fixation System (PMT FFS)Providence Medical Technology, Inc.20227—
+3K211855Ion Facet Screw SystemSurGenTec, LLC202210—
+3K161798FacetBRIDGE® SystemLdr Spine USA, Inc.20160—
+4K261209Ion-LSurGenTec, LLC20260—
+4K251714Ion-CSurGenTec, LLC20260—
+4K253190CORUS-LX ImplantProvidence Medical Technology, Inc.20250—
+4K252153FFX Facet Fixation SystemSc Medica20252—
+4K251885CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX ImplantProvidence Medical Technology, Inc.20251—
+4K243865AERO MIS Facet Fusion SystemAurora Spine20250—
+4K243265Ion 3DSurGenTec, LLC20241—
+4K241035PMT Posterior Cervical Stabilization System (PCSS)Providence Medical Technology, Inc.20244—
+4K232468SC Medica FFXSc Medica20243—
+4K240085zLOCK Lumbar Facet Fixation SystemZygofix, Ltd.20242—
+4K240086Ion 3DSurGenTec, LLC20243—
+4K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+5K253676CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D)Providence Medical Technology, Inc.20260—
+5K250679FFX Facet Fixation SystemSc Medica20250—
+5K242527The Karma® Fixation SystemSpinal Elements, Inc.20250—
+5K242650zLOCK Lumbar Facet Fixation SystemZygofix, Ltd.20240—
+5K241416Ion 3DSurGenTec, LLC20242—