510(k) Report

Devices descending from K061778

154 later devices reach Nuvasive Spherx II System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132014GSB Global Spinal Balance SystemNuvasive, Inc.201382—
+1K092287Nuvasive Spherx II - Pedicle Screw SystemNuvasive, Inc.200972—
+1K091502Nuvasive Spherx II SystemNuvasive, Inc.2009153—
+2K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+2K250908Virata Spinal Fixation SystemSeaSpine Orthopedics Corporation202521
+2K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+2K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+2K171421VERTICALE® Posterior Spinal Fixation System/VERTICALE® SystemSilony Medical GmbH20186—
+2K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+2K160989NuVasive® Reline® SystemNu Vasive, Incorporated201667—
+2K143684NuVasive Reline SystemNu Vasive, Incorporated201577—
+2K142737MAS PLIF Fixation systemNu Vasive, Incorporated20141—
+2K142499Reline SystemNu Vasive, Incorporated201478—
+2K132361Everest Spinal SystemK2m, Inc.201334—
+2K122332Towerlox Pedicle Screw SystemCaptiva Spine201214—
+2K121619Nuvasive Polyaxial Spinal ScrewsNuvasive, Inc.20123—
+2K111410Nuvasive Long Lateral Spinal SystemNuvasive, Inc.20111—
+2K102514Nuvasive Spherx II -Mas Deformity Spinal SystemNuvasive, Inc.201013—
+2K093319Nuvasive Vuepoint Oct SystemNuvasive, Inc.201010—
+3K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+3K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+3K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+3K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+3K223806VERTICALE® Triangular Fixation SystemSilony Medical GmbH20230—
+3K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+3K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+3K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+3K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+3K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+3K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+3K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+3K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+3K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated201841—
+3K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+3K172469TiLock Modular Spinal SystemGenesys Spine20170—
+3K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+3K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—
+3K162576FORTEZZA Spinal Stabilization SystemOsso Surgical20160—
+3K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+3K152781Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20165—
+3K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—
+3K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+3K133374Streamline Oct Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Rti Surgical, I20143—
+3K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine20136—
+3K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135—
+3K122081Nuvasive Long Lateral Spinal SystemNuvasive, Inc.20130—
+3K122352Nuvasive Precept Spinal SystemNuvasive, Inc.20121—
+3K103750Nuvasive Traverse Plate SystemNuvasive, Inc.20111—
+4K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+4K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+4K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+4K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+4K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+4K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+4K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+4K240392JAZZ Spinal SystemImplanet20241—
+4K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+4K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+4K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+4K231931Adena-Zina Spinal SystemShanghai Sanyou Medical Co, Ltd.20230—
+4K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+4K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+4K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+4K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+4K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+4K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+4K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+4K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+4K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+4K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+4K200956NuVasive Thoracolumbar PlatesNu Vasive, Incorporated20200—
+4K193270CapLOX II®/TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20200—
+4K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+4K191575ARx Spinal SystemLife Spine, Inc.201910—
+4K180475CapLOX II® / TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20180—
+4K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20153—
+4K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)201523
+4K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+4K141147Range Spinal SystemK2m, Inc.20141—
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+5K253545Vulcan Spinal SystemK2m, Inc.20260—
+5K252437JAZZ Spinal SystemImplanet20250—
+5K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+5K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+5K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+5K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+5K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+5K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+5K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+5K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+5K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+5K220025ARx® Spinal SystemLife Spine, Inc.20220—
+5K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+5K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+5K200070ARx Spinal SystemLife Spine, Inc.20209—
+5K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+5K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—