510(k) Report

Devices descending from K073515

44 later devices reach TRANS1 Facet Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152137FacetBRIDGE SystemLdr Spine USA20161—
+1K142980Proficient (TM) Facet Screw Spine SystemSpine Wave, Inc.20150—
+1K132126Spectrum Spine Fenestrated Facet Screw SystemSpectrum Spine, LLC201311—
+1K130863Facet Screw SystemSpinal USA20131—
+1K120597KompredaCustom Spine, Inc.20130—
+1K113011Spartan S3 Facet SystemAmendia, Inc.20110—
+1K112097Gibralt Spine Systems Facet Screw 04.0,04.5Exactech, Inc.20110—
+1K101284Facet Screw SystemNuvasive, Inc.20102—
+1K092568Spartan S3 Facet SystemAmendia, Inc.200929—
+1K092464Spineology Facet ScrewSpineology, Inc.20096—
+1K082795Single Use Perpos PLS System, 4.5 Bone-Lok PLS ImplantInterventional Spine, Inc.20088—
+2K253432DiversiVy™ Facet Screw SystemVy Spine, LLC20260—
+2K211855Ion Facet Screw SystemSurGenTec, LLC202210—
+2K163374ALLY™ Facet ScrewsProvidence Medical Technology, Inc.201718—
+2K161798FacetBRIDGE® SystemLdr Spine USA, Inc.20160—
+2K123497Facet Screw SystemFacet-Link, Inc.20131—
+2K120340Venus Facet Screw SystemApollo Spine, Inc.201226—
+2K110170Raptor Facet Fixation SystemAlphatec Spine, Inc.20110—
+2K101762Viper F2 Facet Fixation SystemDepuy Spine, Inc.20101—
+2K102438Primalok Facet Fixation SystemOsteomed LP201041
+2K090767Perpos FCD-2 System (Single Patient Use), Anchor, StabilizerInterventional Spine, Inc.20093—
+3K251714Ion-CSurGenTec, LLC20260—
+3K243865AERO MIS Facet Fusion SystemAurora Spine20250—
+3K243265Ion 3DSurGenTec, LLC20241—
+3K232468SC Medica FFXSc Medica20243—
+3K240085zLOCK Lumbar Facet Fixation SystemZygofix, Ltd.20242—
+3K240086Ion 3DSurGenTec, LLC20243—
+3K230840PMT Facet Fixation System, Lumbar (PMT FFS-LX)Providence Medical Technology, Inc.20239—
+3K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+3K230297PMT Expandable Cage (PMT EXP)Providence Medical Technology, Inc.20230—
+3K192281AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine…Medos International SARL20190—
+3K183589PMT Facet ScrewProvidence Medical Technology, Inc.20198—
+3K150223Facet-Link Stabilization PlatformFacet-Link, Inc.20150—
+4K261209Ion-LSurGenTec, 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—
+4K242527The Karma® Fixation SystemSpinal Elements, Inc.20250—
+4K242650zLOCK Lumbar Facet Fixation SystemZygofix, Ltd.20240—
+4K241416Ion 3DSurGenTec, LLC20242—
+4K220951PMT Facet Fixation System (PMT FFS)Providence Medical Technology, Inc.20227—
+5K250679FFX Facet Fixation SystemSc Medica20250—
+5K241035PMT Posterior Cervical Stabilization System (PCSS)Providence Medical Technology, Inc.20244—
+6K253676CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D)Providence Medical Technology, Inc.20260—