510(k) Report

Devices descending from K130438

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232484KeyLift™ Expandable Interlaminar Stabilization SystemFlospine20230—
+1K143631Benefix Interspinous Fixation SystemU&I Corporation20150—
+1K151863Precision Spine Interspinous Plate SystemPrecision Spine, Inc.20152—
+1K143388Affix IIS Spinous Process Plate SystemNu Vasive, Incorporated20150—
+1K140046Spinous Process Fusion (SPF) PlateSpinal Simplicity, LLC20159—
+1K141508Romeo 2 Pad Posterior Axial DeviceSpineart20141—
+2K221023Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman G3/HA…Spinal Simplicity, LLC20223—
+2K212781Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS Fusion Plate, HA…Spinal Simplicity, LLC20215—
+2K200066Posterior Fusion Plate, HA Posterior Fusion PlateSpinal Simplicity, LLC20206—
+2K161016Z-Clamp ISP SystemZavation, LLC20160—
+2K160465Spinal Elements' Spinous Process Plate SystemSpinal Elements, Inc.20160—
+2K160568Precision Spine Interspinous Plate SystemPrecision Spine, Inc.20160—
+2K151741HA Minuteman G3 MIS Fusion PlateSpinal Simplicity, LLC20158—
+3K233527Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion…Spinal Simplicity, LLC20232—
+3K211880Minuteman G5 MIS Fusion PlateSpinal Simplicity, LLC20224—
+3K163428HA Minuteman G3-R MIS Fusion PlateSpinal Simplicity20177—
+4K234051Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA Posterior Fusion…Spinal Simplicity, LLC20241—
+5K253250Minuteman® G6 MIS Fusion PlateSpinal Simplicity, LLC20250—