510(k) Report

Devices descending from K080401

840 later devices reach Shell Cage, Wave Cage, Loop Cage through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K112444Anatomic Peek Cervical Fusion SystemMedtronic Sofamor Danck USA, Inc.2011324—
+3K111264Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA2011331—
+3K111675VU C*Pod Intervertebral Body Fusion DeviceTheken Spine, LLC201162—
+3K111835Plateau Spacer SystemLife Spine, Inc.2011120—
+4K261049Scala® TLSpineart SA20260—
+4K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+4K242303MOD-COrthomod, LLC20260—
+4K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+4K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+4K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+4K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+4K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+4K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+4K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+4K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+4K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+4K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc.20240—
+4K240699SCARLET® AC-TiSpineart SA20240—
+4K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation20240—
+4K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+4K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+4K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+4K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+4K232150ZSFab Cervical Interbody SystemZsfab, Inc.20234—
+4K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+4K231808QUASAR Standalone ACIF SystemGS Medical Co., Ltd.20230—
+4K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+4K220261NEST-C Interbody SystemPaonan Biotech Co., Ltd.20230—
+4K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+4K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+4K213030Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20233—
+4K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+4K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+4K221266Cervical Spine Truss System (CSTS) Interbody Fusion Device4Web Medical, Inc.20233—
+4K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+4K223510Matrix HA Fusion Porous Cervical IBF SystemInnovasis, Inc.20220—
+4K221172FOCUS Interbody SystemOc Medical Devices20220—
+4K220875HAcancellous PEEK-C Porous HA PEEK Cervical IBF SystemInnovasis, Inc.20224—
+4K220696uCerv Flux-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA20221—
+4K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated20222—
+4K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+4K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+4K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+4K211845Deploy Expandable Interbody SystemSouthern Spine, LLC20210—
+4K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+4K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+4K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+4K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+4K210439NuVasive MOD-EX XLIF Interbody SystemNu Vasive, Incorporated20214—
+4K210359Hexanium TLIFSpinevision, S.A.S.20211—
+4K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+4K202488ZSFab Cervical Interbody SystemZsfab, Inc.20216—
+4K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+4K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+4K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+4K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+4K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+4K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+4K201646Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation202020—
+4K200958MODULIF-A Anterior Lumbar Interbody Fusion SystemSpinal Stability, LLC20200—
+4K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+4K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+4K200312Tryptik TiSpineart20202—
+4K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+4K193203MOJAVE Expandable Interbody SystemK2m, Inc.202015—
+4K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+4K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+4K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+4K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+4K192168Idys ALIF ZP 3DTiClariance, Sas20195—
+4K191134IB3D AlifMedicrea International SA20191—
+4K190426ALTA Anterior Cervical Corpectomy SystemAstura Medical, LLC20193—
+4K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—
+4K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+4K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+4K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+4K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+4K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+4K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+4K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+4K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+4K182158UNiD Patient-matched PLIF cageMedicrea International SA201921—
+4K183243Velofix TLIF CageU&I Corporation20190—
+4K190092UNiD Patient specific 3D printed TLIF cageMedicrea International SA201913—
+4K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar…MiRus, LLC20199—
+4K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+4K182477Cervical SpacerAdditive Implants, LLC201915—
+4K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+4K181589Curiteva Lumbar Interbody Fusion SystemCuriteva, LLC20186—
+4K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—
+4K181829Velofix TLIF CageU&I Corporation20181—
+4K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+4K181818Scarlet AL-TSpineart201864—
+4K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+4K181655Renovis S180 Lateral Lumbar Interbody Fusion SystemRenovis Surgical Technologies20184—
+4K181295Genesys Spine AIS-C Cervical Stand-Alone SystemGenesys Spine201817—
+4K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+4K180777K2M Expandable Interbody SystemK2m, Inc.20180—