510(k) Report

Devices descending from K123045

696 later devices reach Brigade Standalone System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K242273Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation202402
+4K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+4K241332aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar…Carlsmed, Inc.20245—
+4K242509HAnano InterFuse (R) Modular InterbodyNext Orthosurgical20240—
+4K241328aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo®…Carlsmed, Inc.20240—
+4K241846E3D™-C Interbody SystemEvolution Spine20246—
+4K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+4K241019aprevo® TLIF-C Articulating SystemCarlsmed20244—
+4K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+4K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+4K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+4K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+4K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+4K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+4K240623Omnia Medical TiBrid™-SA SystemOmnia Medical, LLC20240—
+4K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+4K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+4K240442MagnetOs PuttyKuros Biosciences B.V20243—
+4K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+4K232282aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal…Carlsmed, Inc.20240—
+4K240507NuVasive AttraX ScaffoldNuvasive, Inc.20240—
+4K240458Synthetic Bone PuttyVentris Medical20242—
+4K240459Cerament Bone Void FillerBonesupport AB20240—
+4K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+4K232432E3D™-A Interbody SystemEvolution Spine20248—
+4K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+4K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+4K232347MagnetOs GranulesKuros Biosciences B.V20242—
+4K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+4K233607MagnetOs Easypack PuttyKuros Biosciences B.V20232—
+4K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+4K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC20232—
+4K232611TruLift Micro Expandable Spacer System & TruLift Expandable Spacer SystemLife Spine, Inc.20232—
+4K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+4K233245MagnetOs Flex MatrixKuros Biosciences B.V20230—
+4K230927OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20231—
+4K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+4K232173Ascend VBR System, Ascend NanoTec VBR SystemAlphatec Spine, Inc.20230—
+4K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+4K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+4K232315Catalyst Bone Void FillerOssdsign AB20237—
+4K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical20232—
+4K231680AccelFix Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20231—
+4K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+4K231275Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc.20232—
+4K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+4K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+4K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+4K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+4K231140aprevo® transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20236—
+4K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+4K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation20230—
+4K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—
+4K223326Axiom PSR SystemRestor3D202301
+4K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+4K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+4K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+4K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+4K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+4K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+4K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+4K221447Southern Anterior Screw Fixated Cage (SASCA)Southern Medical (Pty), Ltd.20220—
+4K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+4K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+4K222561AlignAcuity Surgical Devices, LLC202214—
+4K213641MONDRIAN ALIF Cage with Supplementary Fixation PlateCtl Medical Corporation20221—
+4K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+4K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+4K220610SOLO-LAurora Spine, Inc.20220—
+4K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+4K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+4K213420WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation202211—
+4K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—
+4K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+4K213118Dakota ALIF SystemPrecision Spine, Inc.20220—
+4K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+4K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+4K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+4K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+4K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+4K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+4K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+4K212562Idys-C ZP 3DTiClariance, SA20211—
+4K211740DualXAmplify Surgical, Inc.20211—
+4K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+4K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+4K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+4K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+4K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+4K210542aprevo Transforaminal IBFCarlsmed, Inc.202112—
+4K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+4K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+4K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+4K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.20213—
+4K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+4K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—
+4K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+4K200316UNiD IB3D ALIFMedicrea International SA20200—
+4K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+4K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—