510(k) Report

Devices descending from K050058

727 later devices reach Theken Reveal VBR System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+1K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation201761—
+1K082712Theken Spine VU Epod and VU Lpod SystemTheken Spine, LLC2009118—
+1K080822VU Apod Intervertabral Body Fusion DeviceTheken Spine, LLC20087081
+1K071031VU E*Pod Vertebral Body ReplacementTheken Spine, LLC2007119—
+1K070786X-Pod Adjustable Vertebral Body ReplacementTheken Spine, LLC20070—
+1K070381Theken VU Mesh VBR SystemTheken Spine, LLC200725—
+2K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+2K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+2K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+2K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+2K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+2K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+2K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+2K201646Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation202020—
+2K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+2K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+2K172323Omnia Medical VBROmnia Medical, LLC20176—
+2K142488SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura) NanoMetalene, Cambria…Seaspine, Inc.2014116—
+2K123969XiphosDifusion Technologies201314—
+2K112986Lateral Fusion DeviceIntegra Spine (Integra Lifesciences)2012126—
+2K111294Santorini Spinal SystemK2m, Inc.201218—
+2K112493Pass LP Spinal SystemMedicrea International20111—
+2K112359Prow FusionNlt Spine, Ltd.2011601—
+2K111965Vusion (R) OSOrtho Development20110—
+2K101310VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC2010480—
+2K100544Impix Lumbar Interbody DeviceMedicrea Technologies201001
+2K072537Creaspine Supstance Vertebral Body Replacement SystemCreaspine Sas20071—
+3K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+3K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+3K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+3K243188Cylox® STSignus Medizintechnik GmbH20250—
+3K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+3K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+3K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+3K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+3K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+3K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+3K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC20235—
+3K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+3K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+3K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+3K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+3K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+3K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+3K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+3K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+3K191778Omnia Medical VBROmnia Medical, LLC20195—
+3K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+3K181818Scarlet AL-TSpineart201864—
+3K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+3K173022SeaSpine Ventura NanoMetalene SystemSeaSpine Orthopedics Corporation20170—
+3K171704CAPRI Corpectomy Cage SystemK2m201710—
+3K171046SeaSpine Cambria SystemSeaSpine Orthopedics Corporation201762—
+3K162133VerteFIT Corpectomy Cage SystemLdr Spine USA, Inc.20170—
+3K170055CAPRI Corpectomy Cage SystemK2m201711—
+3K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+3K162715SeaSpine Spacer System- Hollywood NanoMetalene, Hollywood VI NanoMetalene, Ventura…SeaSpine Orthopedics Corporation2016103—
+3K153665Prow Fusion-LNlt Spine, Ltd.20160—
+3K160605MectaLIF Anterior Stand-AloneMedacta International201610—
+3K153720ENZA Zero-Profile Anterior Interbody FusionCamber Spine Technologies20164—
+3K153413PASS LP Spinal SystemMedicrea International SA20160—
+3K151481Sahara Stabilization SystemK2m, Inc.20155—
+3K141942Midline II TICentinel Spine, Inc.2014459—
+3K142016CAPRIK2m, Inc.201412—
+3K133340Spineworks Anterior Lumbar DeviceSpineworks, LLC201413—
+3K133286Midline (TM)Centinel Spine, Inc.2014460—
+3K130254Prow FusionNlt Spine, Ltd.20138—
+3K130461Stalif XCentinel Spine, Inc.201313—
+3K130820Expandable Lumbar Interbody SystemNu Vasive, Incorporated2013593—
+3K124034Mectalif AnteriorMedacta International201311—
+3K121211VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC2012129—
+3K081564Creaspine Supstance Vertebral Body Replacement System Line ExtensionCreaspine20080—
+4K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+4K254202MectaLIF 3D Metal AnteriorMedacta International S.A.20260—
+4K252219Cervical Interbody and VBR Fusion SystemSync Surgical20260—
+4K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+4K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+4K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+4K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+4K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+4K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+4K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+4K242589Scarlet® AL-TSpineart SA20240—
+4K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+4K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+4K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+4K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+4K240368E3D™-A Interbody SystemEvolution Spine20247—
+4K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+4K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+4K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd.20232—
+4K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+4K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+4K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+4K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+4K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+4K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+4K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+4K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—