510(k) Report

Devices descending from K071668

582 later devices reach Orthobiom Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+4K240392JAZZ Spinal SystemImplanet20241—
+4K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+4K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+4K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+4K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+4K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+4K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+4K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+4K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+4K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+4K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+4K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+4K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+4K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+4K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+4K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+4K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+4K223558CUVIS-spineCurexo, Inc.20230—
+4K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+4K222097OLYMPIC Deformity Band SystemAstura Medical20233—
+4K230565HILINE™ Fixation SystemGlobus Medical, Inc.20230—
+4K222105RESPONSE 5.5/6.0 Cannulated Screw SystemOrthoPediatrics Corp.20230—
+4K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+4K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+4K223494CD Horizon Spinal SystemMedtronic202317—
+4K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+4K222473EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra RodsMedos-International Sarl20221—
+4K221023Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman G3/HA…Spinal Simplicity, LLC20223—
+4K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+4K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+4K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+4K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+4K220025ARx® Spinal SystemLife Spine, Inc.20220—
+4K220374EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)Medos International SARL20229—
+4K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+4K212781Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS Fusion Plate, HA…Spinal Simplicity, LLC20215—
+4K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+4K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+4K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+4K201569CUVIS-spineCurexo, Inc.20212—
+4K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+4K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+4K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+4K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+4K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+4K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+4K200066Posterior Fusion Plate, HA Posterior Fusion PlateSpinal Simplicity, LLC20206—
+4K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+4K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+4K202528Cannulated Power Driver AttachmentK2m, Inc.20200—
+4K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+4K200303Reform Pedicle Screw SystemPrecision Spine202010—
+4K200666Stryker Xia 3 Power AdaptorStryker Spine20203—
+4K200281The Gecko Spinal SystemOrtho Development Corporation20200—
+4K200097Response BandLoc Spinal FixationOrthoPediatrics Corp.20200—
+4K200381Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation20202—
+4K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+4K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+4K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+4K190981NEX-D2 Posterior Fixation SystemNext Orthosurgical20200—
+4K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+4K191575ARx Spinal SystemLife Spine, Inc.201910—
+4K191835CREO Stabilization System, Navigation Instruments, ExcelsiusGPS InstrumentsGlobus Medical, Inc.20192—
+4K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+4K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+4K190567KeYi Spinal Fixation SystemBeijing Keyi Medical Device Technology Co., Ltd.20190—
+4K190376PASS LP Spinal SystemMedicrea International SA201915
+4K182771ISS-JAZZ Screw System and JAZZ CAP SPImplanet, S.A.20195—
+4K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+4K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+4K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+4K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+4K182478Whistler Modular Pedicle Screw SystemEvolution Spine, LLC20196—
+4K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+4K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+4K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+4K182240PASS LP Spinal SystemMedicrea International SA20182—
+4K181799ResCUBE™ Ligament Fixation SystemCousin Biotech Sas20180—
+4K181188EVEREST Spinal SystemK2m, Inc.20186—
+4K180433Ennovate®Aesculap Implant Systems, LLC201811
+4K173472MySpine Pedicle Screw Placement Guides – MC and Drill Pilot InstrumentsMedacta International S.A.20185—
+4K172115Navigated Instrument SystemOrthofix, Inc.20184—
+4K180156SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation SystemGlobus Medical, Inc.20185—
+4K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+4K173126Arisstos™ Spinal SystemIngenium Spine20171—
+4K172417SILC® Fixation SystemGlobus Medical, Inc.20171—
+4K172724XIA® 4.5 Spinal System, Power Adaptor Instrument AccessoryStryker Corporation20179—
+4K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+4K171321K2M Navigation InstrumentsK2m201711
+4K172194Connector SystemOrthofix, Inc.2017162
+4K171881JAZZ Passer BandImplanet, S.A.20170—
+4K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+4K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+4K170730JAZZ System, including JAZZ BandImplanet, S.A.20175—
+4K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+4K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+4K161332NILE Proximal Fixation Spinal SystemK2m, Inc.20175—
+4K163604SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation201712—
+4K162576FORTEZZA Spinal Stabilization SystemOsso Surgical20160—