510(k) Report

Devices descending from K123932

18 later devices reach Zygafix Spinal Facet Screw System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180729FaSet Fixation SystemHuvexel Co., Ltd.20183—
+1K152137FacetBRIDGE SystemLdr Spine USA20161—
+1K132126Spectrum Spine Fenestrated Facet Screw SystemSpectrum Spine, LLC201311—
+2K222515FaSet Fixation SystemDio Medical Corporation20222—
+2K211855Ion Facet Screw SystemSurGenTec, LLC202210—
+2K161798FacetBRIDGE® SystemLdr Spine USA, Inc.20160—
+3K251714Ion-CSurGenTec, LLC20260—
+3K243865AERO MIS Facet Fusion SystemAurora Spine20250—
+3K243265Ion 3DSurGenTec, LLC20241—
+3K232468SC Medica FFXSc Medica20243—
+3K240086Ion 3DSurGenTec, LLC20243—
+3K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+3K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+4K252153FFX Facet Fixation SystemSc Medica20252—
+4K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+4K241416Ion 3DSurGenTec, LLC20242—
+5K261209Ion-LSurGenTec, LLC20260—
+5K250679FFX Facet Fixation SystemSc Medica20250—