510(k) Report

Devices descending from K020048

1,559 later devices reach Modification to Geo Structure through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+9K192897icotec Cervical CageIcotec AG20201—
+9K193255Largo PEEK Interbody SystemFlospine, LLC20201—
+9K190284Bengal Stackable Cage SystemMedos International SARL20190—
+9K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+9K190426ALTA Anterior Cervical Corpectomy SystemAstura Medical, LLC20193—
+9K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+9K191748Genesys Spine Sacroiliac Joint Fusion SystemGenesys Spine201922—
+9K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+9K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+9K190885Elevation Spine Saber-C SystemElevation Spine201925—
+9K191423Normandy VBR SystemZavation Medical Products, LLC20193—
+9K190618RIGEL PEEK Anterior Cervical Interbody Fusion SystemMiRus, LLC20191—
+9K191091Rampart One Lumbar Interbody Fusion SystemSpineology, Inc.20191—
+9K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.201912—
+9K173518Spectrum Spine Expandable Cages (SSEC)Spectrum Spine, LLC20196—
+9K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+9K190067Velofix Interbody Fusion SystemU&I Corporation20193—
+9K183510T2 STRATOSPHERE Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201927—
+9K180909REVEL SpacersGlobus Medical, Inc.201837—
+9K181453ATEC ALIF Spacer SystemAlphatec Spine, Inc.2018111—
+9K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+9K181246Zavation IBF SystemZavation Medical Products, LLC201822—
+9K180818Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)Tenon Medical, Inc.201830—
+9K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…Medos International SARL20182—
+9K180642Pro-Link® Ti Stand-Alone Cervical Spacer SystemLife Spine, Inc.20182—
+9K172568CervagePrecifit Medical, Ltd.20181—
+9K173128Alamo® CAlliance Partners, LLC20182—
+9K172115Navigated Instrument SystemOrthofix, Inc.20184—
+9K173324ALTA Anterior Cervical Interbody SpacerAstura Medical201827—
+9K173508Everest Spinal SystemK2m20189—
+9K171434ROCCIA® MultiLIFSilony Medical GmbH20174—
+9K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+9K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+9K171660Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20174—
+9K170962NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated2017304—
+9K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+9K163707NuVasive CoRoent Ti-C SystemNu Vasive, Incorporated201719—
+9K162921Navigated Instrument SystemOrthofix, Inc.20175—
+9K163180Hubble IIOrbbo Surgical, LLC20160—
+9K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+9K162138NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated2016135—
+9K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated201694—
+9K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+9K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, Inc.20163—
+9K153720ENZA Zero-Profile Anterior Interbody FusionCamber Spine Technologies20164—
+9K153250Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies201632—
+9K151726AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK…Stryker Corporation20161391
+9K153373CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical…Medtronic Sofamor Danek2016110—
+9K152972Amendia Stand-Alone Cervical SystemAmendia, Inc.201632
+9K151312VerteLP Interbody Fusion DeviceVgi, LLC201601
+9K152651AccuLIF TL and PL CageStryker Corporation201530—
+9K152304Tritanium PL CageStryker20154481
+9K150788Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion…Meditech Spine, LLC2015202—
+9K151727Everest Spinal SystemK2m, Inc.201511—
+9K150152The Octane Straight Intervertebral Fusion Device, Ti CoatedExactech, Inc.201510—
+9K141599Divergence Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.201516—
+9K142360Everest Spinal SystemK2m, Inc.201522—
+9K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+9K142152Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone SystemOrthofix, Inc.2015280—
+9K142299CoRoent Small Interlock SystemNu Vasive, Incorporated201499—
+9K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+9K141129Exactech Cervical Spacer SystemExactech, Inc.20148—
+9K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+9K140417Divergence Mini-Plate Anterior Cervical Fusion SystemMedtronic Sofamor Danek, Inc.201411—
+9K141147Range Spinal SystemK2m, Inc.20141—
+9K133340Spineworks Anterior Lumbar DeviceSpineworks, LLC201413—
+9K132584Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2013119—
+9K132505Acculif TL and PL CageCoalign Innovations, Inc.20136453
+9K131443Coalign Innovations Acculif XL Ibf CageCoalign Innovations, Inc.20130—
+9K130194Acculif XL CageCoalign Innovations, Inc.20131—
+9K121693A-Wedge Anterior Interbody System (a-Wedge Ais)Sapphire Medical Group, Inc.201221—
+9K121151Pro-Link Cervical Spacer SystemLife Spine, Inc.2012116—
+9K121211VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC2012129—
+10K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+10K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+10K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+10K260660SABER-C SystemElevation Spine20261—
+10K260477CATAMARAN™ SI Joint Fusion SystemTenon Medical20260—
+10K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+10K254061Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20260—
+10K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+10K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—
+10K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+10K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+10K250540SABER-C SystemElevation Spine20252—
+10K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+10K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+10K250403Catamaran SI Joint Fusion SystemTenon Medical20251—
+10K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+10K243188Cylox® STSignus Medizintechnik GmbH20250—
+10K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+10K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+10K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+10K242195Gemini Cervical Fusion Cage SystemZheJiang Decans Medical Devices Co., Ltd.20241—
+10K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+10K241895Cannulated PsiFGuardSpineguard20240—
+10K241813SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20241—
+10K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+10K240721ExcelsiusFlex™Globus Medical, Inc.20240—