510(k) Report

Devices descending from K101471

26 later devices reach Axle Interspinous Fusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K124014Surefix Interspinous Fusion SystemJg Spine, LLC20130—
+1K130438Axle Interspinous Fusion SystemX-Spine Systems, Inc.2013181
+1K122509Vertiflex Spinous Process Fixation PlateVertiflex, Inc.201218—
+2K232484KeyLift™ Expandable Interlaminar Stabilization SystemFlospine20230—
+2K143631Benefix Interspinous Fixation SystemU&I Corporation20150—
+2K151863Precision Spine Interspinous Plate SystemPrecision Spine, Inc.20152—
+2K142217Reliance Interspinous Plate SystemReliance Medical Systems, LLC20150—
+2K143388Affix IIS Spinous Process Plate SystemNu Vasive, Incorporated20150—
+2K140046Spinous Process Fusion (SPF) PlateSpinal Simplicity, LLC20159—
+2K142378Interspinous Plate SystemPrecision Spine, Inc.20143—
+2K141508Romeo 2 Pad Posterior Axial DeviceSpineart20141—
+2K132968Univise Spinous Process Fixation Plate (35MM, 40MM)Stryker Spine201312—
+3K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior…Stryker Corporation20221—
+3K221023Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman G3/HA…Spinal Simplicity, LLC20223—
+3K212781Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS Fusion Plate, HA…Spinal Simplicity, LLC20215—
+3K200066Posterior Fusion Plate, HA Posterior Fusion PlateSpinal Simplicity, LLC20206—
+3K161016Z-Clamp ISP SystemZavation, LLC20160—
+3K160465Spinal Elements' Spinous Process Plate SystemSpinal Elements, Inc.20160—
+3K160568Precision Spine Interspinous Plate SystemPrecision Spine, Inc.20160—
+3K151741HA Minuteman G3 MIS Fusion PlateSpinal Simplicity, LLC20158—
+4K233527Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion…Spinal Simplicity, LLC20232—
+4K230424Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral…Omnia Medical, LLC20230—
+4K211880Minuteman G5 MIS Fusion PlateSpinal Simplicity, LLC20224—
+4K163428HA Minuteman G3-R MIS Fusion PlateSpinal Simplicity20177—
+5K234051Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA Posterior Fusion…Spinal Simplicity, LLC20241—
+6K253250Minuteman® G6 MIS Fusion PlateSpinal Simplicity, LLC20250—