510(k) Report

Devices descending from K061017

50 later devices reach Easyspine System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+1K070341LDR Spine Easyspine Posterior Osteosynthesis SystemLdr Spine USA200717—
+1K063794Modification to Easyspine SystemLdr Spine USA200717—
+2K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+2K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+2K161028K2M Growing Spine SystemK2m, Inc.20163—
+2K161369EVEREST Spinal SystemK2m, Incorporated20169—
+2K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+2K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+2K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+2K123134Easyspine SystemLdr Spine USA, Inc.20131—
+2K121103LDR Spine Usa Spine Tune, TL Spinal System, LDR Spine Usa Easyspine, Posterior Spinal…Ldr Spine USA, Inc.201216—
+3K253545Vulcan Spinal SystemK2m, Inc.20260—
+3K2316554CIS® Chiron Spinal Fixation SystemSolco Biomedical Co., Ltd.20240—
+3K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+3K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+3K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+3K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+3K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+3K181188EVEREST Spinal SystemK2m, Inc.20186—
+3K180376K2M Patient Specific RodsK2m, Inc.20182—
+3K172320Neurostructures Cavetto® Cervical Cage SystemNeurostructures, Inc.20183—
+3K171321K2M Navigation InstrumentsK2m201711
+3K163474CAVUX CervicalCage-L SA SystemProvidence Medical Technology, Inc.20170—
+3K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+3K141129Exactech Cervical Spacer SystemExactech, Inc.20148—
+4K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+4K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+4K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+4K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+4K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+4K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+4K201769Cavetto [MAX] Cervical Cage SystemNeurostructures, Inc.20200—
+4K201006K2M Navigation InstrumentsK2m, Inc.20200—
+4K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+4K181590Neurostructures Cavetto® [MAX] Cervical Cage SystemNeurostructures, Inc.20180—
+4K151727Everest Spinal SystemK2m, Inc.201511—
+4K150130Ascendant TM Cervical Spacer SystemExactech, Inc.20157—
+5K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+5K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+5K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+5K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+5K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+5K203444BEE HA CageNGMedical GmbH20211—
+6K250560BEE HANGMedical GmbH20250—
+6K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+6K240699SCARLET® AC-TiSpineart SA20240—
+6K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+6K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+7K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—