510(k) Report

Devices descending from P960025

1,714 later devices reach Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+1K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+1K180230NEST Interbody SystemPaonan Biotech Co., Ltd.20191—
+1K180228II-Type Intervertebral SpacerPaonan Biotech Co., Ltd.20191—
+1K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+1K181963ostaPek Interbody Fusion CagesColigne AG20181—
+1K181591Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC20180—
+1K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…Medos International SARL20182—
+1K171312FortiCore®Nanovis, LLC20183—
+1K172020Arlington PLIF/TLIF CageSignature Orthopaedics Pty, Ltd.20170—
+1K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+1K171140Matrixx SystemNexxt Spine, LLC2017145—
+1K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+1K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+1K170844Gemini-C Hybrid Cervical Interbody SystemOsseus Fusion Systems, LLC20170—
+1K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemGenesys Spine201611—
+1K152501Spinal Jaxx Interbody Fusion DeviceNeuropro Spinaljaxx, Inc.201601
+1K153615NeoFuse HA Enhanced PLIF/TLIFHt Medical, LLC201650—
+1K153783SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIFSpinevision S.A.201613—
+1K152512Half Dome Posterior Lumbar Interbody SystemAstura Medical201633—
+1K151900VariLift-L Interbody Fusion DeviceWenzel Spine, Inc.20158—
+1K151819Integrity Spine Lumbar Interbody Fusion SystemIntegrity Spine Lumbar Interbody Fusion System20154—
+1K143479Bluefin Interbody SystemTides Medical20152—
+1K150500Px PEEK IBF SystemInnovasis, Inc.201558—
+1K143572Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance…Osteomed Implantes, Ltda20150—
+1K143126Renovis S141 Lumbar Interbody Cage SystemRenovis Surgical Technologies2015237—
+1K132907Plif Lite and Tlif LiteSintea Plustek20140—
+1K133893Sterispine LC CageSafe Orthopaedics20141—
+1K131292Deroyal Spine Spacer SystemDeroyal Industries, Inc.20140—
+1K133126K7 Lumbar SpacersK7, LLC20131—
+1K131981Cezanne II Interbody Fusion SystemAccel Spine201354
+1K131296Varilift-L Interbody Fusion DeviceWenzel Spine, Inc.20130—
+1K131082Interform Interbody Cage SystemNext Orthosurgical2013595—
+1K131671MectalifMedacta International201322—
+1K123100Intess Lumbar CageKalitec Direct, LLC20135—
+1K123207Primalif TM Llif Unitary Peek Lateral Lumbar Interbody Fusion SystemOsteomed LP201216—
+1K122956Fuselox Lumbar Interbody Fusion DeviceCaptiva Spine20122—
+1K121581Box Peek VBR System,Innovasis, Inc.20121—
+1K122021Sterispine LC CageSafe Orthopaedics20122—
+1K120345Honour Spacer SystemNexxt Spine, LLC2012212—
+1K120517Depuy Pulse Cervical Cage SystemMedos International SARL20123—
+1K111820Synster Cervical Cage, Alif Cage, Plif Cage, Ptlif Cage, Tlif CageBm Korea Co., Ltd.201220—
+1K113540Reliance Lumbar Ibf SystemReliance Medical Systems, LLC201212—
+1K111792Mobis, Moval, Semial, Tetrismodel Peek and Titanium, Kimba Model Standard and MiniSignus Medizintechnik GmbH2012470—
+1K120024Mectalif TransforaminalMedacta International S.A.201223—
+1K112664Zavation Ibf SystemsZavation, LLC201137—
+1K1123164-Web Alif Spinal Truss System (STS)4-Web, Inc.20115371
+1K110442Nanovis Intervertebral Body Fusion SystemNanovis, LLC201110—
+1K110562Telamon Peek Spinal SystemMedtronic Sofamor Danek USA2011306—
+1K110694Concorde Bullet Spinal SystemJohnson & Johnson2011227—
+1K111166A-Wedge Anterior Interbody System (a-Wedge a.I.S.)Spineworks, LLC201123—
+1K100305Eturn Spinal Implant Model Eturn XX-12; Eturn XX-16 Where XX=07, 09, 11, 13, or 15 and…Icotec20118—
+1K110927MectalifMedacta International2011301
+1K102957Cutting Edge Spine Interbody Fusion DeviceCutting Edge Spine, LLC201193—
+1K110177Helena SystemRoyal Oak Medical Devices20110—
+1K103111Forza Spacer SystemOrthofix, Inc.20113431
+1K103814Pezo Interbody Cages SystemUlrich GmbH & Co. KG20114—
+1K083894Alif Spinal Truss Interbody Fusion Device4-Web Spine, LLC2011538—
+1K102322Stingray Cervical Cage; Shark Implant (Plif); Bull Shark Implant (Plif); Tiger Implant…Omni Surgical, L.P.20116—
+1K103034Genesys Spine Interbody Fusion SystemGenesys Spine20101371
+1K100516Anyplus Peek CagesGS Medical Co., Ltd.2010636—
+1K102067Endoskeleton toTitan Spine, LLC2010337—
+1K100042Difusion Technologies Xiphos Interbody Fusion SystemDifusion Technologies2010864—
+1K101051Avs a-Lat Peek Spacers, Models 48750XXX, 48751XXX, 48752XXX, 48753XXXStryker Spine2010641—
+1K100865Ava Navigator Peek Spacers, Model 48392XXX, 48393XXXStryker Spine2010637—
+1K100820Wenzel Spine Varilift Interbody Fusion SystemWenzel Spine201016—
+1K101085Spinesmith Cynch Spinal SystemSpine Smith Partners L.P.201001
+1K092901Epicage Interbody Fusion DeviceR Tree Innovations2010609—
+1K094025Crescent Spinal SystemMedtronic Sofamor Danek2010838—
+1K093864Avs Align Peek Spacers Model 48328XXX, 48326XXXStryker Corp.2010637—
+1K093704Avs PL Peek SpacersStryker Corp.2009713—
+1K092017Pivotec Lumbar Interbody Fusion Device (Lifd)Captiva Spine, Inc.200924—
+1K090353Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek2009796—
+1K091122Diana Fusion CageSignus Medical20090—
+1K091638Dorado Wide Intervertebral Body Cage, Models: IM2010-IM2031Spinefrontier, Inc.200915—
+1K081917Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard SystemsDepuy Spine, Inc.20091,008—
+1K090816Stryker Spine Avs PL Peek SpacersStryker Corp.2009756—
+1K090166Avs Anterior Large Peek SpacersStryker Corp.2009683—
+1K083714Endoskeleton TT Interbody Fusion Device (Ibd)Titan Spine, LLC2009412—
+1K090064Eminent Spine Interbody Fusion SystemEminent Spine20097011
+1K090376Spinesmith Cynch Spinal SystemSpine Smith Partners L.P.2009476—
+1K083661Avs TL Peek SpacersStryker Corp.2009757—
+1K081888Dynamik Intervertebral Body Fusion DeviceSpineart2009282—
+1K082801Phantom Plus Cage SystemUs Spine2008643—
+1K082128Depuy Spine Lateral Cage SystemDepuy Spine2008933—
+1K081196Spinal Usa VBR SystemSpinal USA200813—
+1K082014Stryker Spine Avs PL Peek SpacersStryker Corp.2008837—
+1K081177Blackstone Medical, Inc., Pillar Spacer SystemBlackstone Medical, Inc.2008848—
+1K080822VU Apod Intervertabral Body Fusion DeviceTheken Spine, LLC20087081
+1K080401Shell Cage, Wave Cage, Loop CageAdvanced Medical Technologies AG2008840—
+1K073440Foundation CageCorelink, LLC2008126—
+1K073291Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.20081,103—
+1K080083Intrepid Spinal SystemMedtronic Sofamor Danek20089328
+1K080758Avs PL Peek Spacers, Models 48351 and 48353Stryker Corp.20081,091—
+1K073470Avs PL Peek Spacers, Models 48351XXX and 48353XXXStryker Spine20081,102—
+1K072791Oracle Spacer, Opal SpacerSynthes Spine20071,0551
+1K072226Impix SpacerMedicrea Technologies2007812—
+1K072289Spinefrontier Dorado VBRSpinefrontier, Inc.200717—
+1K051819C Change Solution WarmerC Change Surgical, LLC20050—
+2K251016MectaLIF 3D MetalMedacta International S.A.20250—