510(k) Report

Devices descending from K040482

1,621 later devices reach Ebi Esl Spine Spacer System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K123607Octane Elevate Spinal Implant SystemExactech, Inc.20141—
+9K132505Acculif TL and PL CageCoalign Innovations, Inc.20136453
+9K131443Coalign Innovations Acculif XL Ibf CageCoalign Innovations, Inc.20130—
+9K130194Acculif XL CageCoalign Innovations, Inc.20131—
+9K121211VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC2012129—
+10K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+10K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+10K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+10K260477CATAMARAN™ SI Joint Fusion SystemTenon Medical20260—
+10K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+10K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+10K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+10K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+10K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+10K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+10K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+10K250403Catamaran SI Joint Fusion SystemTenon Medical20251—
+10K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+10K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+10K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+10K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+10K241895Cannulated PsiFGuardSpineguard20240—
+10K241813SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20241—
+10K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+10K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+10K240623Omnia Medical TiBrid™-SA SystemOmnia Medical, LLC20240—
+10K232149BowTie™ SI Joint Fusion SystemSail Fusion, LLC20242—
+10K232259Patriot-SI Posterior Implant SystemSpinal Simplicity, LLC20241—
+10K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+10K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+10K233241SOLACE Sacroiliac Fixation SystemHt Medical, LLC Dba Xenix Medical20231—
+10K230857TiLink-P SI Joint Fusion SystemSurGenTec, LLC20234—
+10K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+10K231944CATAMARAN SI Joint Fusion SystemTenon Medical, Inc.20234—
+10K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+10K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+10K223430ProLift Micro Expandable Spacer SystemLife Spine, Inc.20236—
+10K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+10K220274Kisar Stratford SI Screw SystemAnjali Investments L.L.C20230—
+10K213815SiJoin®T3Vgi Medical, Inc.20230—
+10K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC20233—
+10K223819SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20232—
+10K223649VERTICALE® Navigation InstrumentsSilony Medical GmbH20223—
+10K203503Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies, LLC20222—
+10K211496TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20227—
+10K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+10K214059CoreLink Navigation InstrumentsCorelink, LLC20220—
+10K210402Curiteva Sacroiliac Joint Fusion SystemCuriteva, Inc.20212—
+10K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+10K203247iFuse-TORQ™ Implant SystemSI-BONE, Inc.2021171
+10K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+10K182349Concorde LiftMedos International SARL20190—
+10K181014Tritanium PL CageStryker Spine2018137—
+10K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+10K173537Concorde Lift™Medos International SARL20181—
+10K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+10K171519FLXfit™Expanding Orthopedics, Inc.2017711
+10K162236Ax Stand-Alone ALIF SystemInnovasis, Inc.201774—
+10K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+10K141217Acculif TL and PL CageStryker Corporation20146423
+11K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+11K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+11K253921VERTICALE® Navigation InstrumentsSilony Medical GmbH20260—
+11K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+11K250167Evolution Spine Navigation InstrumentsEvolution Spine20250—
+11K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+11K242431Omnia Medical PsiF DNA™ SystemOmnia Medical, LLC20251—
+11K251525SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20250—
+11K250001Patriot SI Implant SystemSpinal Simplicity, LLC20250—
+11K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC20250—
+11K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+11K240505Eminent Spine SI Screw SystemEminent Spine, LLC20241—
+11K240720TiLink-P SI Joint Fusion SystemSurGenTec, LLC20243—
+11K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+11K232878TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20230—
+11K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+11K231951SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20231—
+11K231689iFuse TORQ® Implant SystemSI-BONE, Inc.20235—
+11K230861VADER® Pedicle System Navigated InstrumentsIcotec AG20230—
+11K230989Rod Registration FrameNu Vasive, Incorporated20230—
+11K222605iFuse TORQ® Implant SystemSI-BONE, Inc.202214—
+11K213667iFuse-TORQ® Implant SystemSI-BONE, Inc.202215—
+11K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+11K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+11K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+11K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+11K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+11K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+11K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+12K252834Sacroiliac Joint Truss System (SJTS)4Web Medical20260—
+12K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+12K242414TiLink-P Joint Fusion SystemSurGenTec, LLC20240—
+12K242141TiLink-P SI Joint Fusion SystemSurGenTec, LLC20241—
+12K241574iFuse TORQ® Implant SystemSI-BONE, Inc.20244—
+12K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+12K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+12K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+12K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+12K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+12K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—