510(k) Report

Devices descending from K011037

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+8K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+8K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+8K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+8K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+8K210728CONDUIT InstrumentsMedos International SARL20215—
+8K201024Expandable Titanium PLIF/TLIF SystemSpectrum Spine, LLC20215—
+8K203327VERTACONNECT TLIF CageSignus Medizintechnik20210—
+8K200084Zavation IBF SystemZavation Medical Products, LLC20208—
+8K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+8K191039Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc.201918—
+8K182885Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™…Medtronic Sofamor Danek USA, Inc.20198—
+8K190067Velofix Interbody Fusion SystemU&I Corporation20193—
+8K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20196—
+8K181792Duo™ Lumbar Interbody Fusion DeviceSpineology, Inc.20183—
+8K181014Tritanium PL CageStryker Spine2018137—
+8K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+8K172568CervagePrecifit Medical, Ltd.20181—
+8K180376K2M Patient Specific RodsK2m, Inc.20182—
+8K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+8K171425Concorde LiftMedos International SARL201782
+8K161642CAVUX™ Cervical CageProvidence Medical Technology, Inc.20160—
+8K160646XYcor® Expandable Spinal Spacer SystemAlphatec Spine, Inc.201641—
+8K161028K2M Growing Spine SystemK2m, Inc.20163—
+8K161369EVEREST Spinal SystemK2m, Incorporated20169—
+8K160715AccuLIF TL and PL CageStryker Corporation20160—
+8K153373CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical…Medtronic Sofamor Danek2016110—
+8K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+8K151216Everest Spinal SystemK2m, Inc.201511—
+8K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+8K133402K2M Modular HooksK2m, Inc.20140—
+8K140417Divergence Mini-Plate Anterior Cervical Fusion SystemMedtronic Sofamor Danek, Inc.201411—
+9K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+9K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+9K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+9K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+9K254017SWINGO-3D Lumbar Cage SystemImplanet20260—
+9K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+9K242195Gemini Cervical Fusion Cage SystemZheJiang Decans Medical Devices Co., Ltd.20241—
+9K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+9K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+9K231359RODIN™ Expandable Lumbar Cage SystemCtl Medical Corporation20230—
+9K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+9K192336Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.201917—
+9K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+9K182349Concorde LiftMedos International SARL20190—
+9K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+9K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+9K181188EVEREST Spinal SystemK2m, Inc.20186—
+9K173537Concorde Lift™Medos International SARL20181—
+9K163422Shanghai Sanyou PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20173—
+9K171321K2M Navigation InstrumentsK2m201711
+9K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+9K142450DIVERGENCE Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.20146—
+10K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+10K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+10K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+10K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+10K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+10K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+10K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+10K211689KEYSTONE PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20212—
+10K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+10K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+10K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+10K201006K2M Navigation InstrumentsK2m, Inc.20200—
+11K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+11K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+11K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+11K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+12K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+12K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+12K230989Rod Registration FrameNu Vasive, Incorporated20230—
+13K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—