510(k) Report

Devices descending from K051531

39 later devices reach Tectonic Cervical Plate System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K063544Modification to Pyrenees Cervical Plate SystemK2m, Inc.200738—
+2K153526Pyrenees Cervical Plate SystemK2m20166—
+2K152281Pyrenees Cervical Plate SystemK2m20156—
+2K152015Pyrenees Cervical Plate SystemK2m, Inc.20150—
+2K150983Pyrenees Cervical Plate SystemK2m20157—
+2K142212Pyrenees Cervical Plate SystemK2m, Inc.20150—
+2K113329K2M, Pyrenees Cervical Plate SystemK2m, Inc.201228—
+2K111135Pyrenees Cervical Plate System (Translational Plates)K2m, Inc.20111—
+2K092474Pyrenees Cervical Plate System, Semi-Constrained ScrewsK2m, Inc.20108—
+3K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+3K223321Omnia Medical Coupler-C Anterior Cervical PlateOmnia Medical, LLC20230—
+3K182473PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate…K2m, Inc.20184—
+3K172104Ozark (tm) Cervical Plate SystemK2m, Inc.20175—
+3K162664Pyrenees Cervical Plate SystemK2m, Inc.20165—
+3K130202Iris Anterior Cervical PlateLife Spine, Inc.201321—
+4K253545Vulcan Spinal SystemK2m, Inc.20260—
+4K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior…Stryker Corporation20221—
+4K163104Terrace™ Anterior Cervical Plate SystemCorelink, LLC201718—
+4K152282Cam Lock Plating SystemLife Spine, Inc.20151—
+5K243369Cervical Plating SystemLife Spine, Inc.20240—
+5K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+5K230424Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral…Omnia Medical, LLC20230—
+5K193494Origin™ Anterior Cervical Plate SystemOrthopaedic & Spine Development20200—
+5K190016Lateral Plate SystemCorelink, LLC201915—
+6K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+6K203065Lumbar Spine Truss System Plating Solution (LSTS-PS)4Web, Inc.20219—
+6K202192STRUXXURE®-L and STRUXXURE®-A Plate SystemNexxt Spine, LLC20200—
+7K253201Lumbar Spine Truss System - Plating Solution (LSTS-PS)4Web, Inc.20260—
+7K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+7K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+7K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+7K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+7K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+7K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+7K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+8K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+8K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+8K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+9K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—