510(k) Report

Devices descending from K133052

18 later devices reach Affix (R) Next Gen Spinous Process Plate System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K163471Kalitec Direct InSePtion™ MIS Fixation SystemKalitec Direct, LLC20176—
+1K140046Spinous Process Fusion (SPF) PlateSpinal Simplicity, LLC20159—
+1K132765PFX Spinous Process Fixation SystemInnovasis, Inc.20140—
+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—
+2K180156SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation SystemGlobus Medical, Inc.20185—
+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—
+3K181846ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP…Globus Medical, Inc.20184—
+3K163428HA Minuteman G3-R MIS Fusion PlateSpinal Simplicity20177—
+4K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+4K234051Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA Posterior Fusion…Spinal Simplicity, LLC20241—
+4K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+5K253250Minuteman® G6 MIS Fusion PlateSpinal Simplicity, LLC20250—
+5K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+5K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—