510(k) Report

Devices descending from P980048

1,422 later devices reach Bak/Cervical (Bak/C) Interbody Fusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+2K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+2K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+2K180822VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion SystemWenzel Spine, Inc.20195—
+2K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+2K180909REVEL SpacersGlobus Medical, Inc.201837—
+2K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+2K181140Axis Chena Cervical PEEK Spacer SystemAxis Orthopaedics20182—
+2K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+2K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+2K181295Genesys Spine AIS-C Cervical Stand-Alone SystemGenesys Spine201817—
+2K173947Lumbar Interbody Fusion System (OLLIF)Advanced Research Medical, LLC201801
+2K181261Curiteva Cervical Interbody Fusion SystemCuriteva, LLC20184—
+2K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+2K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…Medos International SARL20182—
+2K173722PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc.201894—
+2K180642Pro-Link® Ti Stand-Alone Cervical Spacer SystemLife Spine, Inc.20182—
+2K180056Genesys Spine AIS-C Cervical Anchored Interbody SystemGenesys Spine201818—
+2K173453Valeo® C+CSC with Lumen Interbody Fusion DeviceAmedica Corp.20180—
+2K173324ALTA Anterior Cervical Interbody SpacerAstura Medical201827—
+2K172320Neurostructures Cavetto® Cervical Cage SystemNeurostructures, Inc.20183—
+2K173077Cavetto-SA Cervical Cage SystemNeurostructures, Inc.201821—
+2K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+2K173102Reliance Cervical IBF SystemReliance Medical Systems, LLC201715—
+2K172330Blustone Synergy Silica SystemBlustone Synergy20170—
+2K172185Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20177—
+2K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+2K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+2K172419Velofix™ TLIF CageU&I Corporation20172—
+2K172424Velofix™ SA Cervical CageU&I Corporation201751
+2K163595IMPIX 3D Print CagesMedicrea International SA2017282
+2K172446SPIRA-C Open Matrix Cervical InterbodyCamber Spine Technologies20176—
+2K173080IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF)Huvexel Co., Ltd.20172—
+2K163366Shanghai Sanyou CARMEN Cervical Fusion SystemShanghai Sanyou Medical Co, Ltd.20170—
+2K172065Scarlet AC-TSpineart20172—
+2K172587Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markersMedacta International S.A.20170—
+2K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+2K172489Reliance Cervical IBF SystemReliance Medical Systems, LLC201716—
+2K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+2K171656Genesys Spine Apache Interbody Fusion SystemGenesys Spine20170—
+2K171749Velofix (tm) Interbody Fusion SystemU&I Corporation20175—
+2K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+2K170297Tranquil Interbody SystemNexus Spine, LLC201715—
+2K163494Summit Spine Channel Cervical Interbody Fusion SystemSummit Spine20171—
+2K162986SPIRA Open Matrix ALIFCamber Spine Technologies201711—
+2K170890TELIX K Interbody SystemBiedermann Motech GmbH & Co. KG20170—
+2K162496Foundation 3D InterbodyCorelink, LLC201782—
+2K163481HALF DOME Posterior Lumbar Interbody SystemAstura Medical201731—
+2K170953Tomcat Cervical Spinal SystemChoicespine, LP2017103—
+2K170643Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201711—
+2K162206Zavation IBFZavation, LLC201724—
+2K163474CAVUX CervicalCage-L SA SystemProvidence Medical Technology, Inc.20170—
+2K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc.2017149—
+2K1624024CIS® Marlin ACIF Cage SystemSolco Biomedical Co., Ltd.20171—
+2K162531Sterispine CCSafe Orthopaedics20160—
+2K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc.20166—
+2K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL2016111—
+2K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.20165—
+2K160663Lumbar Interbody Fusion System (ALIF, PLIF, LLIF, TPLIF)Evolution Spine, LLC20160—
+2K161649Virtu C Spinal Implant SystemMet 1 Technologies, LLC20162—
+2K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemGenesys Spine201611—
+2K161642CAVUX™ Cervical CageProvidence Medical Technology, Inc.20160—
+2K153665Prow Fusion-LNlt Spine, Ltd.20160—
+2K152099Genesys Spine Apache® Anchored Cervical Interbody Fusion SystemGenesys Spine201619—
+2K161404Genesys Spine Apache® Lateral Lumbar Interbody Fusion SystemGenesys Spine201610—
+2K160874Nanovis Intervertebral Body Fusion System and FortiCore®Nanovis, LLC20164—
+2K153517AnyPlus® Cervical PEEK Cage SystemGS Medical Co., Ltd.201612—
+2K160324Cervical Interbody Fusion SystemEvolution Spine, LLC20162—
+2K153123Genesys Spine Apache Interbody Fusion SystemGenesys Spine201612—
+2K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers…Globus Medical, Inc.2016210—
+2K153250Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies201632—
+2K151665SUSTAIN Additional ImplantsGlobus Medical, Inc.2016119—
+2K153438PERIMETER C (Titanium) Spinal SystemMedtronic Sofamor Danek USA, Inc.20160—
+2K153373CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical…Medtronic Sofamor Danek2016110—
+2K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+2K152532AERO -C Cervical Cage SystemStryker Spine2015145—
+2K152355Twin Peaks Lumbar Interbody Fusion SystemSpineway20151—
+2K151352CONCORDE Bullet Spinal SystemMedos International SARL20153—
+2K151408LOSPA IS Spinal SystemCorentec Co., Ltd.20151—
+2K150812Genesys Spine Apache Cervical Interbody Fusion SystemGenesys Spine201512—
+2K150673SYNFIX Evolution Secured Spacer SystemSynthes (USA) Products, LLC2015137—
+2K150847Foundation Interbody DevicesCorelink, LLC201529—
+2K150500Px PEEK IBF SystemInnovasis, Inc.201558—
+2K142269Reliance Cervical IBF SystemReliance Medical Systems, LLC201523—
+2K142586Captiva Spine FuselOX Cervical IBF SystemCaptiva Spine20150—
+2K150521Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201512—
+2K142744Mecta-C TiPEEKMedacta International201512—
+2K142218Coalition AGX Plate and Coalition AGX SpacerGlobus Medical, Inc.2015155—
+2K143214SCARLET® AC-T Secured Anterior Cervical CageSpineart20153—
+2K141798Sypher Spacer SystemBiogennix, LLC20151—
+2K142996StaXx (R) XD SystemSpine Wave, Inc.20150—
+2K142940Endoskeleton TCS SystemTitan Spine, LLC20151112
+2K141599Divergence Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.201516—
+2K141187Impix Alif S/aMedicrea International SA201501
+2K142328nvcNvision Biomedical Technologies, LLC20144—
+2K142041Porosteon Phusion Metal Cervical CagePorosteon, Inc.20141—
+2K133218Crystal ®; Mosaic ®; Vertu ®Spinal Elements, Inc.2014130—
+2K142594nva, nvp, nvtNvision Biomedical Technologies, LLC20144—
+2K141333Arena-C Tifuse Cervical Intervertebral Body Fusion DeviceSpinefrontier, Inc.20140—
+2K141953Endoskeleton; TA Ibd and VBR, to and TT, Tas, TC, TLTitan Spine, LLC20142652
+2K142026Spinefrontier Arena-C HA Peek Cervical Intervertebral Body Fusion DeviceSpinefrontier, Inc.2014190—