510(k) Report

Devices descending from K122967

615 later devices reach Lucent through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+4K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+4K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+4K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+4K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+4K181397DualXInnovasive, Inc.201815—
+4K181386NuVasive Brigade Lateral SystemNu Vasive, Incorporated2018158—
+4K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+4K180480ATEC Universal Spacer SystemAlphatec Spine, Inc.2018113—
+4K173892NuVasive® XLX Interbody SystemNu Vasive, Incorporated2018115—
+4K180078Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF SystemInnovasis, Inc.2018551
+4K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+4K171495Zyston Strut Open Titanium Spacer SystemZimmer Biomet Spine, Inc.20181—
+4K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+4K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+4K171046SeaSpine Cambria SystemSeaSpine Orthopedics Corporation201762—
+4K170962NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated2017304—
+4K162496Foundation 3D InterbodyCorelink, LLC201782—
+4K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL2016111—
+4K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+4K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+4K153665Prow Fusion-LNlt Spine, Ltd.20160—
+4K160958Battalion Universal Spacer SystemAlphatec Spine2016114—
+4K153419NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated2016400—
+4K143479Bluefin Interbody SystemTides Medical20152—
+5K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—
+5K261408SABER-XA SystemElevation Spine20260—
+5K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+5K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+5K261430TruLift Expandable SystemLife Spine, Inc.20260—
+5K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+5K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+5K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+5K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+5K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+5K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+5K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+5K253260ORIO-3D Cage SystemSpineCraft20260—
+5K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+5K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+5K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+5K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+5K251479Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage…Mobarn Medical Devices, LLC20250—
+5K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—
+5K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+5K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+5K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+5K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+5K241525ExcelsiusXR™Globus Medical, Inc.20250—
+5K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+5K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+5K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+5K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+5K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+5K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+5K243474MagnetOs MISKuros Biosciences B.V20250—
+5K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+5K250373ProLift Expandable Spacer SystemLife Spine, Inc.20251—
+5K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+5K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+5K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+5K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+5K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+5K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+5K242734ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemZsfab20243—
+5K242589Scarlet® AL-TSpineart SA20240—
+5K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+5K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+5K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+5K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+5K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+5K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+5K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+5K240368E3D™-A Interbody SystemEvolution Spine20247—
+5K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+5K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+5K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+5K240453ReBOSSISOrthorebirth Co., Ltd.202402
+5K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+5K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+5K234013Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20243—
+5K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+5K232611TruLift Micro Expandable Spacer System & TruLift Expandable Spacer SystemLife Spine, Inc.20232—
+5K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+5K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+5K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+5K232173Ascend VBR System, Ascend NanoTec VBR SystemAlphatec Spine, Inc.20230—
+5K231076VariLift®-C Interbody Fusion SystemWenzel Spine, Inc.20234—
+5K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+5K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+5K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical20232—
+5K231680AccelFix Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20231—
+5K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+5K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+5K231275Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc.20232—
+5K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+5K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+5K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+5K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation20230—
+5K223326Axiom PSR SystemRestor3D202301