510(k) Report

Devices descending from K030866

339 later devices reach Synthes Anterior CSLP System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K171567IRIX-A Lumbar Integrated Fusion SystemX-Spine Systems, Inc.201701
+5K170830Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20175—
+5K152972Amendia Stand-Alone Cervical SystemAmendia, Inc.201632
+5K142269Reliance Cervical IBF SystemReliance Medical Systems, LLC201523—
+6K263049SABER-C SystemElevation Spine20260—
+6K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+6K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+6K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+6K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+6K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+6K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+6K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+6K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+6K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+6K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+6K241846E3D™-C Interbody SystemEvolution Spine20246—
+6K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+6K240201PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20240—
+6K232318VICTORY™ Lumbar Plate SystemGlobus Medical, Inc.20230—
+6K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC20231—
+6K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+6K230329F3D Interbody SystemCorelink, LLC20230—
+6K223140AEON-C™ Stand Alone SystemDio Medical, Inc.20222—
+6K221162UniVy OsteoVy Cervical IBF SystemVy Spine, LLC20222—
+6K212358Romero Cervical CageSpineup, Inc.20226—
+6K212715Vy Spine ClariVy Cervical IBF SystemVy Spine, LLC20216—
+6K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+6K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+6K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+6K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+6K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+6K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+6K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+6K172489Reliance Cervical IBF SystemReliance Medical Systems, LLC201716—
+6K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.20165—
+7K261049Scala® TLSpineart SA20260—
+7K262094E3D™-C Interbody SystemEvolution Spine20260—
+7K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+7K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+7K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+7K260038E3D™-C Interbody SystemEvolution Spine20261—
+7K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+7K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+7K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+7K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+7K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+7K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+7K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+7K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage SystemCtl Medical Corporation20240—
+7K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+7K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+7K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+7K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+7K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+7K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+7K240368E3D™-A Interbody SystemEvolution Spine20247—
+7K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+7K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+7K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+7K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+7K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+7K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+7K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+7K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+7K230026SqualeImplanet, S.A.20230—
+7K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+7K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+7K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+7K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.202212—
+7K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+7K221936Standalone ALIF Interbody Fusion SystemEminent Spine20222—
+7K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal…Carlsmed, Inc.202211—
+7K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+7K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+7K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+7K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+7K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+7K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+7K201671A-Link ZAcuity Surgical Devices, LLC202125—
+7K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+7K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—
+7K201087CORBEL SpacersGlobus Medical, Inc.202036—
+7K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+8K261408SABER-XA SystemElevation Spine20260—
+8K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+8K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+8K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+8K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+8K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+8K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+8K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+8K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—
+8K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+8K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+8K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+8K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+8K241477aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20246—
+8K241332aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar…Carlsmed, Inc.20245—
+8K241328aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo®…Carlsmed, Inc.20240—
+8K241019aprevo® TLIF-C Articulating SystemCarlsmed20244—