510(k) Report

Devices descending from K042201

796 later devices reach Novel VBR Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K242273Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation202402
+8K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+8K242509HAnano InterFuse (R) Modular InterbodyNext Orthosurgical20240—
+8K241846E3D™-C Interbody SystemEvolution Spine20246—
+8K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+8K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+8K240368E3D™-A Interbody SystemEvolution Spine20247—
+8K240623Omnia Medical TiBrid™-SA SystemOmnia Medical, LLC20240—
+8K240442MagnetOs PuttyKuros Biosciences B.V20243—
+8K240715Idys® C ZP 3DTiClariance20240—
+8K240507NuVasive AttraX ScaffoldNuvasive, Inc.20240—
+8K240458Synthetic Bone PuttyVentris Medical20242—
+8K240459Cerament Bone Void FillerBonesupport AB20240—
+8K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+8K232432E3D™-A Interbody SystemEvolution Spine20248—
+8K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+8K232347MagnetOs GranulesKuros Biosciences B.V20242—
+8K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+8K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+8K233607MagnetOs Easypack PuttyKuros Biosciences B.V20232—
+8K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC20232—
+8K233245MagnetOs Flex MatrixKuros Biosciences B.V20230—
+8K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+8K230927OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20231—
+8K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC20231—
+8K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+8K231076VariLift®-C Interbody Fusion SystemWenzel Spine, Inc.20234—
+8K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+8K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+8K232315Catalyst Bone Void FillerOssdsign AB20237—
+8K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+8K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+8K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+8K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+8K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+8K223418DeGen Impulse AM™ SystemDegen Medical20236—
+8K223231Ti-Largo Cervical Interbody SystemFlospine20230—
+8K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+8K223494CD Horizon Spinal SystemMedtronic202317—
+8K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+8K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+8K223140AEON-C™ Stand Alone SystemDio Medical, Inc.20222—
+8K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+8K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.202212—
+8K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+8K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+8K221936Standalone ALIF Interbody Fusion SystemEminent Spine20222—
+8K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+8K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+8K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal…Carlsmed, Inc.202211—
+8K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+8K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+8K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+8K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+8K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+8K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+8K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+8K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+8K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+8K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+8K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+8K210590Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20210—
+8K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation20217—
+8K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+8K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+8K211306LabyrinthZavation Medical Products, LLC20213—
+8K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+8K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+8K201671A-Link ZAcuity Surgical Devices, LLC202125—
+8K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+8K201024Expandable Titanium PLIF/TLIF SystemSpectrum Spine, LLC20215—
+8K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+8K203576FORZA Ti Spacer SystemOrthofix, Inc.202161
+8K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+8K203327VERTACONNECT TLIF CageSignus Medizintechnik20210—
+8K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—
+8K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+8K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc.202010—
+8K201646Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation202020—
+8K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+8K201087CORBEL SpacersGlobus Medical, Inc.202036—
+8K193172Luna XD Ti Interbody Fusion SystemBenvenue Medical, Inc.20201—
+8K200352Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20202—
+8K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+8K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+8K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+8K192993Scarlet AL-TSpineart20201—
+8K191834Stand-Alone ALIF Titanium SystemLife Spine, Inc.20190—
+8K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+8K191339Zavation eZspand Interbody SystemZavation Medical Products, LLC20195—
+8K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+8K182158UNiD Patient-matched PLIF cageMedicrea International SA201921—
+8K190877Juliet® Ti LL Lumbar Interbody DeviceSpineart201911
+8K191091Rampart One Lumbar Interbody Fusion SystemSpineology, Inc.20191—
+8K190092UNiD Patient specific 3D printed TLIF cageMedicrea International SA201913—
+8K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.201912—
+8K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar…MiRus, LLC20199—
+8K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+8K180822VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion SystemWenzel Spine, Inc.20195—
+8K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20196—