510(k) Report

Devices descending from K011037

1,374 later devices reach Vertebral Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K193255Largo PEEK Interbody SystemFlospine, LLC20201—
+6K193521Steerable Plateau TiLife Spine, Inc.20201—
+6K193258ProLift Expandable SystemLife Spine, Inc.20203—
+6K192993Scarlet AL-TSpineart20201—
+6K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+6K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20195—
+6K190284Bengal Stackable Cage SystemMedos International SARL20190—
+6K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+6K192248Cortina™ [MAX] Lumbar Cage SystemNeurostructures, Inc.20190—
+6K190721LongBow TiLife Spine, Inc.20190—
+6K192168Idys ALIF ZP 3DTiClariance, Sas20195—
+6K191134IB3D AlifMedicrea International SA20191—
+6K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+6K190426ALTA Anterior Cervical Corpectomy SystemAstura Medical, LLC20193—
+6K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+6K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+6K190483SPIRA Open Matrix ALIF and LLIFCamber Spine Technologies20199—
+6K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+6K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+6K183407Triton CageMedyssey USA, Inc.20190—
+6K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+6K182158UNiD Patient-matched PLIF cageMedicrea International SA201921—
+6K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20197—
+6K183064TxTi IBF SystemInnovasis, Inc.2019481
+6K182139AXTi Titanium Stand-Alone ALIF SystemInnovasis, Inc.201972—
+6K190684LxHA PEEK Lateral IBF SystemInnovasis, Inc.20190—
+6K191263Idys ALIF TiVacClariance, Sas20190—
+6K190618RIGEL PEEK Anterior Cervical Interbody Fusion SystemMiRus, LLC20191—
+6K190877Juliet® Ti LL Lumbar Interbody DeviceSpineart201911
+6K190092UNiD Patient specific 3D printed TLIF cageMedicrea International SA201913—
+6K190165Capstone Control™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20196—
+6K190655SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201974—
+6K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.201912—
+6K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+6K190193SpineEX Sagittae® Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20192—
+6K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine20195—
+6K183049Reliance Lumbar IBF SystemReliance Medical Systems, LLC20197—
+6K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH2019131—
+6K180822VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion SystemWenzel Spine, Inc.20195—
+6K183071VLIFT-s Vertebral Body Replacement SystemStryker Spine20194—
+6K183239CoreLink F3D™ Lateral SystemCorelink, LLC20188—
+6K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—
+6K182470Plateau Spacer SystemLife Spine20180—
+6K181921Solidity Vertebral Body ReplacementUlrich Medical USA20182—
+6K181829Velofix TLIF CageU&I Corporation20181—
+6K181644EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH2018141—
+6K181328T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201828—
+6K180556Corelink Foundation 3D Anterior Lumbar SystemCorelink, LLC20185—
+6K181453ATEC ALIF Spacer SystemAlphatec Spine, Inc.2018111—
+6K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+6K180673Normandy VBR SystemZavation Medical Products, LLC20187—
+6K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…Medos International SARL20182—
+6K180687Reliance Lumber IBF SystemReliance Medical Systems20188—
+6K180642Pro-Link® Ti Stand-Alone Cervical Spacer SystemLife Spine, Inc.20182—
+6K180071STYLO Interbody Fusion DeviceLegend Spine Technologies20180—
+6K173782UNiD Patient Specific 3D printed cageMedicrea International SA201823—
+6K180431Cortina [MAX] Lumbar Cage SystemNeurostructures, Inc.20181—
+6K173324ALTA Anterior Cervical Interbody SpacerAstura Medical201827—
+6K173535Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody…Titan Spine, LLC20181052
+6K171495Zyston Strut Open Titanium Spacer SystemZimmer Biomet Spine, Inc.20181—
+6K171434ROCCIA® MultiLIFSilony Medical GmbH20174—
+6K172888EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH2017159—
+6K172419Velofix™ TLIF CageU&I Corporation20172—
+6K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+6K172253Altus Spine Cervical Interbody Fusion SystemAltus Partners, LLC20170—
+6K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device4Web, Inc.20171—
+6K172064Ti-Diagon Oblique TLIFCamber Spine Technologies201727—
+6K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc.20177—
+6K171704CAPRI Corpectomy Cage SystemK2m201710—
+6K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+6K170919The TiBow Expandable Spacer SystemLife Spine, Inc.20171—
+6K170962NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated2017304—
+6K163506Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar…Vertera, Inc.2017224—
+6K162986SPIRA Open Matrix ALIFCamber Spine Technologies201711—
+6K170395Talos® Lumbar (HA) PEEK IBF DevicesMeditech Spine, LLC201710—
+6K163707NuVasive CoRoent Ti-C SystemNu Vasive, Incorporated201719—
+6K162206Zavation IBFZavation, LLC201724—
+6K163543Biomet Fusion SystemZimmer Biomet Spine, Inc.2017124—
+6K162918Atlas Spine Expandable Interbody SystemAtlas Spine, Inc.201729—
+6K163180Hubble IIOrbbo Surgical, LLC20160—
+6K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc.20163—
+6K162944Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc.20161—
+6K162138NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated2016135—
+6K160074Rampart D Lumbar Interbody Fusion DeviceSpineology, Inc.20165—
+6K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, Inc.20163—
+6K161404Genesys Spine Apache® Lateral Lumbar Interbody Fusion SystemGenesys Spine201610—
+6K160906Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device…Spineology, Inc.201627—
+6K152501Spinal Jaxx Interbody Fusion DeviceNeuropro Spinaljaxx, Inc.201601
+6K153436LATERAL Spine Truss System4Web, Inc.20165—
+6K160463Reliance Lumbar IBF SystemReliance Medical Systems, LLC201611—
+6K153720ENZA Zero-Profile Anterior Interbody FusionCamber Spine Technologies20164—
+6K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T…Ldr Spine USA20161891
+6K151726AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK…Stryker Corporation20161391
+6K151312VerteLP Interbody Fusion DeviceVgi, LLC201601
+6K151773CONCORDE Bullet Lumbar Interbody SystemMedos International SARL2015201—
+6K152304Tritanium PL CageStryker20154481
+6K151756Sterispine LC CageSafe Orthopaedics20150—
+6K151374NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable…Nu Vasive, Incorporated2015235—
+6K142559ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015130—
+6K150130Ascendant TM Cervical Spacer SystemExactech, Inc.20157—