510(k) Report

Devices descending from K050391

148 later devices reach Protex CT Cervicothoracic Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+5K201006K2M Navigation InstrumentsK2m, Inc.20200—
+5K173508Everest Spinal SystemK2m20189—
+5K151727Everest Spinal SystemK2m, Inc.201511—
+5K142360Everest Spinal SystemK2m, Inc.201522—
+5K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+5K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+5K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+5K141147Range Spinal SystemK2m, Inc.20141—
+6K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+6K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+6K262094E3D™-C Interbody SystemEvolution Spine20260—
+6K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+6K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+6K260038E3D™-C Interbody SystemEvolution Spine20261—
+6K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+6K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+6K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+6K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+6K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+6K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+6K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+6K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+6K180376K2M Patient Specific RodsK2m, Inc.20182—
+6K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+6K161028K2M Growing Spine SystemK2m, Inc.20163—
+6K161369EVEREST Spinal SystemK2m, Incorporated20169—
+6K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+6K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+6K151216Everest Spinal SystemK2m, Inc.201511—
+6K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+6K133402K2M Modular HooksK2m, Inc.20140—
+7K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+7K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+7K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+7K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+7K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+7K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+7K181188EVEREST Spinal SystemK2m, Inc.20186—
+7K171321K2M Navigation InstrumentsK2m201711
+7K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+8K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+8K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+8K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+8K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+9K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+9K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+9K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—