510(k) Report

Devices descending from K021039

32 later devices reach Bowti Anterior Buttress Staple System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192281AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine…Medos International SARL20190—
+1K143065NuVasive ALIF Buttress Plate SystemNu Vasive, Incorporated20151—
+1K133911Genesys Spine Anterior Buttress Plate SystemGenesys Spine201416—
+1K073349Reliance Buttress Washer SystemReliance Medical Systems, LLC20081—
+1K061385Osstaple, Ossplate, OssforceBiomedical Enterprises, Inc.20071—
+1K062181C-Jaws Cervical Compressive Mini FrameMedicrea Technologies20073—
+1K041105Macropore Hydrosorb Spine SystemMacropore Biosurgery, Inc.20044—
+1K040130Anterior Lumbar Buttress SystemSeaspine20044—
+2K261309Palisades™ Buttress Plate SystemBethesda Medical Devices, LLC20260—
+2K213219Vy Spine™ VyWasher™ Buttress SystemVy Spine, LLC20210—
+2K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+2K173091Boundary Anterior Lumbar Buttress PlateNvision Biomedical Technologies, LLC20170—
+2K063461Anova Containment DeviceAnova Corporation20090—
+2K071810Inion Spinal Graft Containment SystemInion, Ltd.20081—
+2K073500Active Anterior Cervical Plate SystemSanacor20080—
+2K072040C-Jaws Cervical Compressive Mini FrameMedicrea Technologies20070—
+2K051821Inion S-1 Biodegradable Anterior Cervical Fusion SystemInion, Ltd.20052—
+3K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+3K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+3K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+3K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+3K151360Inion Spinal Graft Containment SystemInion OY20150—
+4K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+4K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+4K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+4K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+4K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+4K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+4K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+4K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+5K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+5K242517ProAM ACDF SystemPro Surgical, Inc.20240—