510(k) Report

Devices descending from K091088

901 later devices reach LDR Spine Cervical Interbody Fusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+2K180076Ti 3Z Interbody SystemZavation Medical Products, LLC20184—
+2K181246Zavation IBF SystemZavation Medical Products, LLC201822—
+2K172788MONET™ Anterior Cervical Interbody Fusion Cage SystemCtl Medical Corporation20181—
+2K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…Medos International SARL20182—
+2K172480icotec Interbody Cage SystemIcotec AG20185—
+2K173324ALTA Anterior Cervical Interbody SpacerAstura Medical201827—
+2K172320Neurostructures Cavetto® Cervical Cage SystemNeurostructures, Inc.20183—
+2K173077Cavetto-SA Cervical Cage SystemNeurostructures, Inc.201821—
+2K172212MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™Ctl Medical Corporation20181—
+2K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation201761—
+2K172424Velofix™ SA Cervical CageU&I Corporation201751
+2K163366Shanghai Sanyou CARMEN Cervical Fusion SystemShanghai Sanyou Medical Co, Ltd.20170—
+2K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+2K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+2K171656Genesys Spine Apache Interbody Fusion SystemGenesys Spine20170—
+2K170503EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH20171992
+2K161710Sagico Ibf System – Aria Lumbar, Sagico Ibf System – Arion CervicalSpinal Analytics & Geometrical Impant Co, LLC201741—
+2K163481HALF DOME Posterior Lumbar Interbody SystemAstura Medical201731—
+2K163474CAVUX CervicalCage-L SA SystemProvidence Medical Technology, Inc.20170—
+2K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemGenesys Spine201611—
+2K161485Nanovis Intervertebral Body Fusion System and Forticore (R)Nanovis, LLC20165—
+2K161404Genesys Spine Apache® Lateral Lumbar Interbody Fusion SystemGenesys Spine201610—
+2K160874Nanovis Intervertebral Body Fusion System and FortiCore®Nanovis, LLC20164—
+2K153123Genesys Spine Apache Interbody Fusion SystemGenesys Spine201612—
+2K152568C-VBRCardinal Spine, LLC201657—
+2K151939COALITION SpacersGlobus Medical, Inc.2016152—
+2K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+2K152972Amendia Stand-Alone Cervical SystemAmendia, Inc.201632
+2K152515TOMCAT Cervical Spinal SystemChoicespine, LP2015108—
+2K153122Endoskeleton (r) TCS SystemTitan Spine, LLC20151061
+2K151934ROI-C Titanium-Coated Implant SystemLdr Spine USA20159—
+2K151596Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC20151101
+2K150765LDR Spine ROI-C Cervical Cage SystemLdr Spine USA201559—
+2K150812Genesys Spine Apache Cervical Interbody Fusion SystemGenesys Spine201512—
+2K151064Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small…Biomet Spine201517—
+2K151198A-CIFT SoloFuseSpinefrontier, Inc.20158—
+2K150130Ascendant TM Cervical Spacer SystemExactech, Inc.20157—
+2K150913Incite Anchored Cervical Interbody DeviceIncite Innovation20150—
+2K142392Zavation Posterior LEIFZavation, LLC20150—
+2K143360LnK Cervical Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20159—
+2K143214SCARLET® AC-T Secured Anterior Cervical CageSpineart20153—
+2K141798Sypher Spacer SystemBiogennix, LLC20151—
+2K142030STGC-LordoticCardinal Spine, LLC201558—
+2K141599Divergence Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.201516—
+2K142152Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone SystemOrthofix, Inc.2015280—
+2K142328nvcNvision Biomedical Technologies, LLC20144—
+2K142271Zavation Z-Link LumbarZavation, LLC20149—
+2K142594nva, nvp, nvtNvision Biomedical Technologies, LLC20144—
+2K141314Scarlet AC-T Secured Anterior Cervical Cage and Associated InstrumentationSpineart201438—
+2K140280ForticoreNanovis, LLC20149—
+2K140003Coroent Small Interbody SystemNuvasive, Inc.2014453—
+2K132991C-Box Peek Cervical IbfInnovasis, Inc.20149—
+2K132582Exactech Acapella One Cervical Spacer SystemExactech, Inc.2014471
+2K130913Genesys Spine Apache Lateral Lumbar Interbody Fusion SystemGenesys Spine201314—
+2K130317Genesys Spine Apache Ibfd Star Cervical SystemGenesys Spine20139—
+2K132584Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2013119—
+2K130853Idys (TM) CClariance20132—
+2K131981Cezanne II Interbody Fusion SystemAccel Spine201354
+2K130948C-Fuse Cervical Intervertebral Body Fusion SystemSouthern Spine, LLC201313—
+2K122801Providence Cervical CageProvidence Medical Technology, Inc.20131—
+2K130306Incite Anchored Cervical Interbody DeviceIncite Innovation, LLC20131—
+2K122037Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail…Medtronic Sofamor Danek, Inc.2013281—
+2K122518Synster (Cervical,Alif, Plif, Ptlif and Tlif) Cage Hera Cervical Cage Rhea Plif Cage…Bm Korea Co., Ltd.20133—
+2K123134Easyspine SystemLdr Spine USA, Inc.20131—
+2K120603Varilift -CWenzel Spine2013193—
+2K121151Pro-Link Cervical Spacer SystemLife Spine, Inc.2012116—
+2K120401Alamo TAlliance Partners, LLC20121—
+2K122021Sterispine LC CageSafe Orthopaedics20122—
+2K120819Stalif CCentinel Spine, Inc.2012206—
+2K120966Depuy Pulse Lumbar Cage SystemMedos International SARL201225—
+2K120275Synthes Acis/Vertebral Spacer CRSynthes (Usa), LLC2012173—
+2K113796Solitaire-C Cervical Spacer SystemEbi, LLC20121421
+2K111820Synster Cervical Cage, Alif Cage, Plif Cage, Ptlif Cage, Tlif CageBm Korea Co., Ltd.201220—
+2K120024Mectalif TransforaminalMedacta International S.A.201223—
+2K112862Mecta-CMedacta International201114—
+2K112444Anatomic Peek Cervical Fusion SystemMedtronic Sofamor Danck USA, Inc.2011324—
+2K111264Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA2011331—
+2K111439Chesapeake (Cervical Components)K2m, Inc.20113451
+2K100967Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2011121—
+2K111675VU C*Pod Intervertebral Body Fusion DeviceTheken Spine, LLC201162—
+3K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+3K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20260—
+3K2530413d Cage CervicalFims Co., Ltd.20260—
+3K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+3K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+3K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+3K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+3K261067BEE PLIF CageNGMedical GmbH20260—
+3K252774Uni-C Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+3K242303MOD-COrthomod, LLC20260—
+3K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+3K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+3K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+3K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+3K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+3K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+3K2316554CIS® Chiron Spinal Fixation SystemSolco Biomedical Co., Ltd.20240—
+3K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+3K241846E3D™-C Interbody SystemEvolution Spine20246—
+3K241467Stable-C Interbody SystemNexus Spine, LLC20242—