510(k) Report

Devices descending from K080728

903 later devices reach LDR Spine Roi-C Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K181295Genesys Spine AIS-C Cervical Stand-Alone SystemGenesys Spine201817—
+4K181483Tranquil Interbody SystemNexus Spine, LLC20186—
+4K180076Ti 3Z Interbody SystemZavation Medical Products, LLC20184—
+4K181246Zavation IBF SystemZavation Medical Products, LLC201822—
+4K172788MONET™ Anterior Cervical Interbody Fusion Cage SystemCtl Medical Corporation20181—
+4K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…Medos International SARL20182—
+4K172480icotec Interbody Cage SystemIcotec AG20185—
+4K173324ALTA Anterior Cervical Interbody SpacerAstura Medical201827—
+4K172320Neurostructures Cavetto® Cervical Cage SystemNeurostructures, Inc.20183—
+4K173077Cavetto-SA Cervical Cage SystemNeurostructures, Inc.201821—
+4K172212MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™Ctl Medical Corporation20181—
+4K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation201761—
+4K172424Velofix™ SA Cervical CageU&I Corporation201751
+4K163366Shanghai Sanyou CARMEN Cervical Fusion SystemShanghai Sanyou Medical Co, Ltd.20170—
+4K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+4K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+4K171656Genesys Spine Apache Interbody Fusion SystemGenesys Spine20170—
+4K170503EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH20171992
+4K161710Sagico Ibf System – Aria Lumbar, Sagico Ibf System – Arion CervicalSpinal Analytics & Geometrical Impant Co, LLC201741—
+4K163481HALF DOME Posterior Lumbar Interbody SystemAstura Medical201731—
+4K163474CAVUX CervicalCage-L SA SystemProvidence Medical Technology, Inc.20170—
+4K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemGenesys Spine201611—
+4K161485Nanovis Intervertebral Body Fusion System and Forticore (R)Nanovis, LLC20165—
+4K161404Genesys Spine Apache® Lateral Lumbar Interbody Fusion SystemGenesys Spine201610—
+4K160874Nanovis Intervertebral Body Fusion System and FortiCore®Nanovis, LLC20164—
+4K153123Genesys Spine Apache Interbody Fusion SystemGenesys Spine201612—
+4K152568C-VBRCardinal Spine, LLC201657—
+4K151939COALITION SpacersGlobus Medical, Inc.2016152—
+4K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+4K152972Amendia Stand-Alone Cervical SystemAmendia, Inc.201632
+4K152515TOMCAT Cervical Spinal SystemChoicespine, LP2015108—
+4K153122Endoskeleton (r) TCS SystemTitan Spine, LLC20151061
+4K151934ROI-C Titanium-Coated Implant SystemLdr Spine USA20159—
+4K151596Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC20151101
+4K150765LDR Spine ROI-C Cervical Cage SystemLdr Spine USA201559—
+4K150812Genesys Spine Apache Cervical Interbody Fusion SystemGenesys Spine201512—
+4K151064Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small…Biomet Spine201517—
+4K151198A-CIFT SoloFuseSpinefrontier, Inc.20158—
+4K150130Ascendant TM Cervical Spacer SystemExactech, Inc.20157—
+4K150913Incite Anchored Cervical Interbody DeviceIncite Innovation20150—
+4K142392Zavation Posterior LEIFZavation, LLC20150—
+4K143360LnK Cervical Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20159—
+4K143214SCARLET® AC-T Secured Anterior Cervical CageSpineart20153—
+4K141798Sypher Spacer SystemBiogennix, LLC20151—
+4K142030STGC-LordoticCardinal Spine, LLC201558—
+4K141599Divergence Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.201516—
+4K142152Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone SystemOrthofix, Inc.2015280—
+4K142328nvcNvision Biomedical Technologies, LLC20144—
+4K142271Zavation Z-Link LumbarZavation, LLC20149—
+4K142594nva, nvp, nvtNvision Biomedical Technologies, LLC20144—
+4K141314Scarlet AC-T Secured Anterior Cervical Cage and Associated InstrumentationSpineart201438—
+4K140280ForticoreNanovis, LLC20149—
+4K140003Coroent Small Interbody SystemNuvasive, Inc.2014453—
+4K132991C-Box Peek Cervical IbfInnovasis, Inc.20149—
+4K132582Exactech Acapella One Cervical Spacer SystemExactech, Inc.2014471
+4K130913Genesys Spine Apache Lateral Lumbar Interbody Fusion SystemGenesys Spine201314—
+4K130317Genesys Spine Apache Ibfd Star Cervical SystemGenesys Spine20139—
+4K132584Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2013119—
+4K130853Idys (TM) CClariance20132—
+4K131981Cezanne II Interbody Fusion SystemAccel Spine201354
+4K130948C-Fuse Cervical Intervertebral Body Fusion SystemSouthern Spine, LLC201313—
+4K122801Providence Cervical CageProvidence Medical Technology, Inc.20131—
+4K130306Incite Anchored Cervical Interbody DeviceIncite Innovation, LLC20131—
+4K122037Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail…Medtronic Sofamor Danek, Inc.2013281—
+4K122518Synster (Cervical,Alif, Plif, Ptlif and Tlif) Cage Hera Cervical Cage Rhea Plif Cage…Bm Korea Co., Ltd.20133—
+4K123134Easyspine SystemLdr Spine USA, Inc.20131—
+4K120603Varilift -CWenzel Spine2013193—
+4K121151Pro-Link Cervical Spacer SystemLife Spine, Inc.2012116—
+4K120401Alamo TAlliance Partners, LLC20121—
+4K122021Sterispine LC CageSafe Orthopaedics20122—
+4K120819Stalif CCentinel Spine, Inc.2012206—
+4K120966Depuy Pulse Lumbar Cage SystemMedos International SARL201225—
+4K120275Synthes Acis/Vertebral Spacer CRSynthes (Usa), LLC2012173—
+4K113796Solitaire-C Cervical Spacer SystemEbi, LLC20121421
+4K111820Synster Cervical Cage, Alif Cage, Plif Cage, Ptlif Cage, Tlif CageBm Korea Co., Ltd.201220—
+4K120024Mectalif TransforaminalMedacta International S.A.201223—
+4K112862Mecta-CMedacta International201114—
+4K112444Anatomic Peek Cervical Fusion SystemMedtronic Sofamor Danck USA, Inc.2011324—
+4K111264Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA2011331—
+4K111439Chesapeake (Cervical Components)K2m, Inc.20113451
+4K100967Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2011121—
+4K111675VU C*Pod Intervertebral Body Fusion DeviceTheken Spine, LLC201162—
+5K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+5K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20260—
+5K2530413d Cage CervicalFims Co., Ltd.20260—
+5K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+5K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+5K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+5K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+5K261067BEE PLIF CageNGMedical GmbH20260—
+5K252774Uni-C Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+5K242303MOD-COrthomod, LLC20260—
+5K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+5K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+5K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+5K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+5K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+5K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+5K2316554CIS® Chiron Spinal Fixation SystemSolco Biomedical Co., Ltd.20240—
+5K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412