510(k) Report

Devices descending from K091502

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K161028K2M Growing Spine SystemK2m, Inc.20163—
+5K161369EVEREST Spinal SystemK2m, Incorporated20169—
+5K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+5K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20160—
+5K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+5K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+5K133402K2M Modular HooksK2m, Inc.20140—
+6K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+6K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+6K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+6K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+6K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+6K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+6K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+6K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+6K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+6K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+6K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+6K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+6K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+6K222789VADER® Pedicle System, G21 CementIcotec AG202352
+6K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+6K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+6K210549ARx Spinal SystemLife Spine, Inc.20211—
+6K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+6K182470Plateau Spacer SystemLife Spine20180—
+6K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+6K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+6K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+6K181188EVEREST Spinal SystemK2m, Inc.20186—
+6K180376K2M Patient Specific RodsK2m, Inc.20182—
+6K171321K2M Navigation InstrumentsK2m201711
+6K172139Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20170—
+6K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+7K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+7K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+7K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+7K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+7K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+7K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+7K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+7K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+7K232628VADER® Pedicle SystemIcotec AG20241—
+7K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+7K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+7K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+7K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+7K201006K2M Navigation InstrumentsK2m, Inc.20200—
+7K151727Everest Spinal SystemK2m, Inc.201511—
+8K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+8K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+8K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+8K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—