510(k) Report

Devices descending from K101084

62 later devices reach Caspian Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+1K142558Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m20140—
+1K141284Caspian Spinal SystemK2m, Inc.20140—
+1K133288Caspian Oct Spinal SystemK2m, Inc.201418—
+1K113654CaspianK2m, Inc.201244—
+1K103232Caspian Spinal SystemK2m, Inc.201146—
+2K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+2K193129Yukon OCT Spinal SystemK2m, Inc.202001
+2K182182YUKON OCT Spinal SystemK2m20185—
+2K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+2K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+2K121808Casian, 3.5/4.5 ConnectorsK2m, Inc.20121—
+2K120656Everest Spinal SystemK2m, Inc.201243—
+3K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+3K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+3K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+3K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+3K140529Everest Spinal SystemK2m, LLC201431—
+3K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+3K132757Everest Spinal SystemK2m, Inc.201341—
+3K132361Everest Spinal SystemK2m, Inc.201334—
+4K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+4K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+4K253545Vulcan Spinal SystemK2m, Inc.20260—
+4K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+4K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+4K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+4K173508Everest Spinal SystemK2m20189—
+4K151727Everest Spinal SystemK2m, Inc.201511—
+4K142360Everest Spinal SystemK2m, Inc.201522—
+4K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+4K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+4K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+4K141147Range Spinal SystemK2m, Inc.20141—
+5K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+5K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+5K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+5K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+5K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+5K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+5K180376K2M Patient Specific RodsK2m, Inc.20182—
+5K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+5K161028K2M Growing Spine SystemK2m, Inc.20163—
+5K161369EVEREST Spinal SystemK2m, Incorporated20169—
+5K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+5K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+5K151216Everest Spinal SystemK2m, Inc.201511—
+5K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+5K133402K2M Modular HooksK2m, Inc.20140—
+6K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+6K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+6K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+6K181188EVEREST Spinal SystemK2m, Inc.20186—
+6K171321K2M Navigation InstrumentsK2m201711
+6K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+7K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+7K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+7K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+7K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+7K201006K2M Navigation InstrumentsK2m, Inc.20200—
+8K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+8K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—