510(k) Report

Devices descending from K100354

37 later devices reach Primal OK Interspinous Fusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231807primaLOK™ SP Interspinous Fusion SystemWenzel Spine, Inc.20230—
+1K160465Spinal Elements' Spinous Process Plate SystemSpinal Elements, Inc.20160—
+1K142217Reliance Interspinous Plate SystemReliance Medical Systems, LLC20150—
+1K142378Interspinous Plate SystemPrecision Spine, Inc.20143—
+1K133363Interbridge Interspinous Posterior Fixation SystemLdr Spine USA, Inc.20145—
+1K131238Affix Spinous Process Plate SystemNuvasive, Inc.201330—
+1K122509Vertiflex Spinous Process Fixation PlateVertiflex, Inc.201218—
+1K121316Lanx Spinal Fization SystemLanx, Inc.20123—
+2K173334SeaSpine Spinous Process SystemSeaSpine Orthopedics Corporation20180—
+2K160568Precision Spine Interspinous Plate SystemPrecision Spine, Inc.20160—
+2K151863Precision Spine Interspinous Plate SystemPrecision Spine, Inc.20152—
+2K141508Romeo 2 Pad Posterior Axial DeviceSpineart20141—
+2K133052Affix (R) Next Gen Spinous Process Plate SystemNuvasive, Inc.201318—
+2K132968Univise Spinous Process Fixation Plate (35MM, 40MM)Stryker Spine201312—
+2K131156Lanx Spinal Fixation SystemLanx, Inc.20131—
+3K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior…Stryker Corporation20221—
+3K202309Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty Fixation System, Concero…Zimmer Biomet Spine, Inc.20200—
+3K163471Kalitec Direct InSePtion™ MIS Fixation SystemKalitec Direct, LLC20176—
+3K161016Z-Clamp ISP SystemZavation, LLC20160—
+3K140046Spinous Process Fusion (SPF) PlateSpinal Simplicity, LLC20159—
+3K132765PFX Spinous Process Fixation SystemInnovasis, Inc.20140—
+4K230424Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral…Omnia Medical, LLC20230—
+4K221023Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman G3/HA…Spinal Simplicity, LLC20223—
+4K212781Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS Fusion Plate, HA…Spinal Simplicity, LLC20215—
+4K200066Posterior Fusion Plate, HA Posterior Fusion PlateSpinal Simplicity, LLC20206—
+4K180156SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation SystemGlobus Medical, Inc.20185—
+4K151741HA Minuteman G3 MIS Fusion PlateSpinal Simplicity, LLC20158—
+5K233527Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion…Spinal Simplicity, LLC20232—
+5K211880Minuteman G5 MIS Fusion PlateSpinal Simplicity, LLC20224—
+5K181846ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP…Globus Medical, Inc.20184—
+5K163428HA Minuteman G3-R MIS Fusion PlateSpinal Simplicity20177—
+6K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+6K234051Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA Posterior Fusion…Spinal Simplicity, LLC20241—
+6K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+7K253250Minuteman® G6 MIS Fusion PlateSpinal Simplicity, LLC20250—
+7K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+7K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—