510(k) Report

Devices descending from K032476

753 later devices reach Nuvasive Mesh through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+7K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+7K260810Anteralign LS coverplateTyber Medical, LLC20260—
+7K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+7K261067BEE PLIF CageNGMedical GmbH20260—
+7K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+7K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+7K242303MOD-COrthomod, LLC20260—
+7K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+7K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+7K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+7K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+7K253545Vulcan Spinal SystemK2m, Inc.20260—
+7K260038E3D™-C Interbody SystemEvolution Spine20261—
+7K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+7K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+7K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+7K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+7K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+7K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+7K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+7K251479Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage…Mobarn Medical Devices, LLC20250—
+7K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+7K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+7K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—
+7K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+7K243673Xenco Medical CancelleX Cervical Interbody SystemXenco Medical, LLC20250—
+7K243668ProLift Pivot Expandable Spacer SystemLife Spine, Inc.20250—
+7K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+7K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+7K242589Scarlet® AL-TSpineart SA20240—
+7K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage SystemCtl Medical Corporation20240—
+7K242457EARP Interbody SystemRetropsoas Technologies, LLC20240—
+7K2402503D Printed PEEK Interbody SystemNvision Biomedical Technologies, Inc.20240—
+7K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+7K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+7K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+7K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+7K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+7K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+7K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+7K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+7K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+7K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+7K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+7K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+7K231704Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer SystemLife Spine, Inc.20230—
+7K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd.20232—
+7K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+7K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+7K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+7K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+7K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+7K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+7K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+7K223868PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.20232—
+7K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+7K223326Axiom PSR SystemRestor3D202301
+7K230583Tryptik TiSpineart SA20231—
+7K223418DeGen Impulse AM™ SystemDegen Medical20236—
+7K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+7K222041CYGNUS-C Standalone ACIF SystemGS Medical Co., Ltd.20231—
+7K223494CD Horizon Spinal SystemMedtronic202317—
+7K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+7K223251Hexanium PLIFSpinevision, S.A.S.20220—
+7K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+7K223510Matrix HA Fusion Porous Cervical IBF SystemInnovasis, Inc.20220—
+7K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+7K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+7K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+7K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+7K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+7K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+7K222561AlignAcuity Surgical Devices, LLC202214—
+7K220875HAcancellous PEEK-C Porous HA PEEK Cervical IBF SystemInnovasis, Inc.20224—
+7K221325CONDUIT Lateral Switch PlateMedos International SARL20221—
+7K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+7K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+7K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+7K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+7K220610SOLO-LAurora Spine, Inc.20220—
+7K213420WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation202211—
+7K212477EARP Interbody SystemNvision Biomedical Technologies, Inc.20221—
+7K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+7K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+7K212358Romero Cervical CageSpineup, Inc.20226—
+7K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+7K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…Nu Vasive, Incorporated202166—
+7K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+7K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+7K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+7K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+7K212562Idys-C ZP 3DTiClariance, SA20211—
+7K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+7K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+7K211413BEE PLIF CageNGMedical GmbH20211—
+7K211501Advantage-C PEEK Cervical lnterbody Fusion DeviceLntelivation, LLC20211—
+7K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+7K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+7K203003Pantheon IBFDPantheon Spinal20210—