510(k) Report

Devices descending from K082801

643 later devices reach Phantom Plus Cage System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203—
+1K1624024CIS® Marlin ACIF Cage SystemSolco Biomedical Co., Ltd.20171—
+1K153517AnyPlus® Cervical PEEK Cage SystemGS Medical Co., Ltd.201612—
+1K153783SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIFSpinevision S.A.201613—
+1K132582Exactech Acapella One Cervical Spacer SystemExactech, Inc.2014471
+1K132991C-Box Peek Cervical IbfInnovasis, Inc.20149—
+1K1217414-Web Cervical STS (Spinal Truss System)4-Web, Inc.201235—
+1K122085Stingray Cervical CageOmni Surgical, LP Dba Spine36020120—
+1K121892Phantom Plus Ceramic Cage SystemAmedica Corp.20127—
+1K103655Octane-C Interbody Fusion Device SystemExactech, Inc.2011481
+1K101363VU Cpod Intervertebral Bodu Fusion DeviceMusculoskeletal Clinical Regulatory Advisers201078—
+1K093093Small Plateau Spacer SystemLife Spine2010393—
+1K100889Endoskeleton TCTitan Spine, LLC2010455—
+2K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20261—
+2K241738PYXIS 3D Titanium Cervical Cage systemGS Medical Co., Ltd.20241—
+2K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+2K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation20230—
+2K222041CYGNUS-C Standalone ACIF SystemGS Medical Co., Ltd.20231—
+2K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+2K223251Hexanium PLIFSpinevision, S.A.S.20220—
+2K213641MONDRIAN ALIF Cage with Supplementary Fixation PlateCtl Medical Corporation20221—
+2K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+2K200592GS Medical AnyPlus PEEK Cage SystemGS Medical Co., Ltd.20206—
+2K1920444CIS Marlin PEEK ACIF CageSolco Biomedical Co., Ltd.20190—
+2K191796Neo Cage SystemNeo Medical SA20190—
+2K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+2K183092Kuros TLIF CageKuros Biosciences B.V20190—
+2K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+2K181048Neo Cage System TMNeo Medical SA20191—
+2K181115CxHA PEEK Cervical IBF SystemInnovasis, Inc.20188—
+2K181261Curiteva Cervical Interbody Fusion SystemCuriteva, LLC20184—
+2K180437Hexanium® TLIFSpinevision, S.A.S.20182—
+2K180056Genesys Spine AIS-C Cervical Anchored Interbody SystemGenesys Spine201818—
+2K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+2K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation201761—
+2K172446SPIRA-C Open Matrix Cervical InterbodyCamber Spine Technologies20176—
+2K171489Acapella Cervical Spacer SystemChoicespine, LP201739—
+2K170844Gemini-C Hybrid Cervical Interbody SystemOsseus Fusion Systems, LLC20170—
+2K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc.20166—
+2K161405Valeo II Interbody Fusion Device SystemAmedica Corp.20164—
+2K152099Genesys Spine Apache® Anchored Cervical Interbody Fusion SystemGenesys Spine201619—
+2K160154ALTA Anterior Cervical Interbody SpacerAstura Medical201663—
+2K142940Endoskeleton TCS SystemTitan Spine, LLC20151112
+2K142347Amedica Valeo II Interbody Fusion DeviceAmedica Corp.20145—
+2K141953Endoskeleton; TA Ibd and VBR, to and TT, Tas, TC, TLTitan Spine, LLC20142652
+2K142589Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS, Endoskeleton TAS…Titan Spine, LLC2014106—
+2K1421124WEB Spinal Implant Products4Web, Inc.201433—
+2K121649Construx Mini Peek TI Spacer SystemOrthofix2012289—
+2K112862Mecta-CMedacta International201114—
+2K112444Anatomic Peek Cervical Fusion SystemMedtronic Sofamor Danck USA, Inc.2011324—
+2K111264Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA2011331—
+2K111675VU C*Pod Intervertebral Body Fusion DeviceTheken Spine, LLC201162—
+2K111835Plateau Spacer SystemLife Spine, Inc.2011120—
+3K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20260—
+3K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+3K242303MOD-COrthomod, LLC20260—
+3K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+3K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+3K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+3K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+3K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+3K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+3K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+3K240699SCARLET® AC-TiSpineart SA20240—
+3K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation20240—
+3K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+3K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+3K231808QUASAR Standalone ACIF SystemGS Medical Co., Ltd.20230—
+3K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+3K213030Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20233—
+3K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+3K221266Cervical Spine Truss System (CSTS) Interbody Fusion Device4Web Medical, Inc.20233—
+3K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+3K223510Matrix HA Fusion Porous Cervical IBF SystemInnovasis, Inc.20220—
+3K220875HAcancellous PEEK-C Porous HA PEEK Cervical IBF SystemInnovasis, Inc.20224—
+3K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+3K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+3K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+3K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+3K210359Hexanium TLIFSpinevision, S.A.S.20211—
+3K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+3K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+3K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+3K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+3K201646Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation202020—
+3K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+3K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+3K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+3K190426ALTA Anterior Cervical Corpectomy SystemAstura Medical, LLC20193—
+3K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+3K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+3K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+3K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+3K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+3K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+3K181589Curiteva Lumbar Interbody Fusion SystemCuriteva, LLC20186—
+3K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+3K181295Genesys Spine AIS-C Cervical Stand-Alone SystemGenesys Spine201817—
+3K180695FBC 921 (Alif)Fbc Device Aps20180—
+3K180675Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc.20182—