510(k) Report

Devices descending from K050058

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K221545MectaLIF Anterior ExtensionMedacta International S.A.202226
+4K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+4K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—
+4K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+4K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+4K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+4K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+4K202637F3D Corpectomy SystemCorelink, LLC20201—
+4K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+4K201585Monterey AL Interbody SystemStryker Corporation202044
+4K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+4K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+4K200048MectaLIF Anterior SimpleMedacta International S.A.20200—
+4K192906Mecta-C Stand AloneMedacta International S.A.20201—
+4K192993Scarlet AL-TSpineart20201—
+4K190877Juliet® Ti LL Lumbar Interbody DeviceSpineart201911
+4K183426MectaLIF Anterior Stand Alone ExtensionMedacta International S.A.20191—
+4K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—
+4K180963Roccia Alif, Roccia TlifSilony Medical GmbH20183—
+4K173347STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX…Centinel Spine, Inc.201812—
+4K172019Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd.20170—
+4K170569SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201782—
+4K162236Ax Stand-Alone ALIF SystemInnovasis, Inc.201774—
+4K170455MectaLIF Anterior Stand AloneMedacta International S.A.20174—
+4K153105MLX™ - Medial Lateral Expandable Lumbar Interbody SystemNu Vasive, Incorporated2016234—
+4K153123Genesys Spine Apache Interbody Fusion SystemGenesys Spine201612—
+4K150673SYNFIX Evolution Secured Spacer SystemSynthes (USA) Products, LLC2015137—
+4K151654Prow FusionNlt Spine, Ltd.20151—
+4K151214ALIF Interfixated SystemNu Vasive, Incorporated2015220—
+4K150643Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc.2015368—
+4K141665NuVasive CoRoent SystemNuvasive, Inc.2015588—
+4K142023Luna Interbody SystemBenvenue Medical, Inc.20145—
+4K140770MLX - Medial Lateral Expandable Lumbar Interbody SystemNu Vasive, Incorporated2014269—
+4K140162AP Expandable Xlif SystemNuvasive, Inc.2014236—
+5K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+5K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+5K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+5K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+5K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+5K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+5K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+5K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+5K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+5K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+5K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+5K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+5K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+5K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+5K241846E3D™-C Interbody SystemEvolution Spine20246—
+5K241321Juliet® Ti LL Lumbar Interbody DeviceSpineart SA20240—
+5K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+5K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+5K240699SCARLET® AC-TiSpineart SA20240—
+5K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+5K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+5K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+5K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+5K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+5K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+5K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+5K232123MectaLIF Anterior Lag ExtensionMedacta International S.A.20231—
+5K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+5K230329F3D Interbody SystemCorelink, LLC20230—
+5K223326Axiom PSR SystemRestor3D202301
+5K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+5K212612Omnia Medical TiBrid-SCOmnia Medical, LLC20220—
+5K221447Southern Anterior Screw Fixated Cage (SASCA)Southern Medical (Pty), Ltd.20220—
+5K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+5K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+5K213420WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation202211—
+5K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+5K213118Dakota ALIF SystemPrecision Spine, Inc.20220—
+5K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+5K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+5K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+5K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+5K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—
+5K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+5K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+5K200953NuVasive® Cohere® Thoracolumbar Interbody SystemNu Vasive, Incorporated2020141—
+5K201506Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical…Meditech Spine, LLC20200—
+5K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+5K193412NEXXT MATRIXX SystemNexxt Spine, LLC20201—
+5K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+5K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+5K190483SPIRA Open Matrix ALIF and LLIFCamber Spine Technologies20199—
+5K190680Favo S-TlifSilony Medical GmbH20190—
+5K182139AXTi Titanium Stand-Alone ALIF SystemInnovasis, Inc.201972—
+5K190655SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201974—
+5K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+5K180215DYNA-LINK ELITE Stand-Alone Anterior Lumbar SystemLife Spine, Inc.20182—
+5K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+5K180695FBC 921 (Alif)Fbc Device Aps20180—
+5K173892NuVasive® XLX Interbody SystemNu Vasive, Incorporated2018115—
+5K180002Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+5K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+5K173025NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP…Nu Vasive, Incorporated20188—
+5K173182ProLift® Expandable SystemLife Spine, Inc.201737—
+5K172009Cascadia Interbody SystemK2m, Inc.2017433
+5K163595IMPIX 3D Print CagesMedicrea International SA2017282