510(k) Report

Devices descending from K092108

42 later devices reach Truss Thoracolumbar Plate System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+1K213820BALTEUM - ONE™ Lumbar Plate SystemHuvexel Co., Ltd.20223—
+1K181846ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP…Globus Medical, Inc.20184—
+1K120092Plymouth Thoracolumbar Plate SystemGlobus Medical, Inc.201241—
+2K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+2K222572FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and…Dio Medical Corporation20222—
+2K200846Balteum™ Lumbar Plate SystemHuvexel Co., Ltd.20204—
+2K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+2K190016Lateral Plate SystemCorelink, LLC201915—
+2K183214Raven Lumbar Plate SystemChoicespine, LP20192—
+2K1721312 Hole Lateral Plating SystemLife Spine, Inc.201710—
+2K140260Skyhawk Lateral Plate SystemOrthofix, Inc.201414—
+3K260015ANTERIS Thoracolumbar Plate SystemSpineCraft20260—
+3K250446Frida™ Anterior Cervical Plate SystemSpineup, Inc.20250—
+3K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+3K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+3K231460FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System…K&J Consulting Corp.20230—
+3K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+3K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+3K203065Lumbar Spine Truss System Plating Solution (LSTS-PS)4Web, Inc.20219—
+3K202192STRUXXURE®-L and STRUXXURE®-A Plate SystemNexxt Spine, LLC20200—
+3K180166Life Spine Lumbar Fixation System (SENTRY)Life Spine, Inc.20189—
+3K160362Z-Span Plate SystemZavation, LLC20163—
+4K253201Lumbar Spine Truss System - Plating Solution (LSTS-PS)4Web, Inc.20260—
+4K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+4K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+4K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+4K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+4K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+4K222628Life Spine ALIF Buttress Plate SystemLife Spine, Inc.20220—
+4K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+4K202624Z-Span Plate SystemZavation Medical Products, LLC20201—
+4K200956NuVasive Thoracolumbar PlatesNu Vasive, Incorporated20200—
+4K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+4K162824Z-Span Plate SystemZavation, LLC20172—
+5K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+5K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+5K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+5K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+5K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+6K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+6K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—