510(k) Report

Devices descending from K092287

72 later devices reach Nuvasive Spherx II - Pedicle Screw System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171421VERTICALE® Posterior Spinal Fixation System/VERTICALE® SystemSilony Medical GmbH20186—
+1K132361Everest Spinal SystemK2m, Inc.201334—
+1K122332Towerlox Pedicle Screw SystemCaptiva Spine201214—
+1K121619Nuvasive Polyaxial Spinal ScrewsNuvasive, Inc.20123—
+1K093319Nuvasive Vuepoint Oct SystemNuvasive, Inc.201010—
+2K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+2K223806VERTICALE® Triangular Fixation SystemSilony Medical GmbH20230—
+2K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+2K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+2K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+2K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+2K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+2K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+2K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+2K162576FORTEZZA Spinal Stabilization SystemOsso Surgical20160—
+2K152781Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20165—
+2K142737MAS PLIF Fixation systemNu Vasive, Incorporated20141—
+2K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+2K133374Streamline Oct Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Rti Surgical, I20143—
+2K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine20136—
+3K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+3K240392JAZZ Spinal SystemImplanet20241—
+3K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+3K231931Adena-Zina Spinal SystemShanghai Sanyou Medical Co, Ltd.20230—
+3K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+3K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+3K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+3K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+3K193270CapLOX II®/TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20200—
+3K180475CapLOX II® / TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20180—
+3K172469TiLock Modular Spinal SystemGenesys Spine20170—
+3K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20153—
+3K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)201523
+3K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+3K141147Range Spinal SystemK2m, Inc.20141—
+4K253545Vulcan Spinal SystemK2m, Inc.20260—
+4K252437JAZZ Spinal SystemImplanet20250—
+4K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+4K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+4K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+4K161498Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20161—
+4K161028K2M Growing Spine SystemK2m, Inc.20163—
+4K161369EVEREST Spinal SystemK2m, Incorporated20169—
+4K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+4K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20160—
+4K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+4K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+4K133402K2M Modular HooksK2m, Inc.20140—
+5K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+5K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+5K182470Plateau Spacer SystemLife Spine20180—
+5K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+5K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+5K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+5K181188EVEREST Spinal SystemK2m, Inc.20186—
+5K180376K2M Patient Specific RodsK2m, Inc.20182—
+5K171321K2M Navigation InstrumentsK2m201711
+5K172139Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20170—
+5K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+6K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+6K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+6K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+6K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+6K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+6K201006K2M Navigation InstrumentsK2m, Inc.20200—
+6K151727Everest Spinal SystemK2m, Inc.201511—
+7K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+7K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+7K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+7K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+8K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+8K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—