510(k) Report

Devices descending from K033826

135 later devices reach Orthopedic Alliance Spine System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K171838TiLock2 Spinal SystemGenesys Spine20174—
+5K163428HA Minuteman G3-R MIS Fusion PlateSpinal Simplicity20177—
+5K152132X-spine Pedicle Screw SystemX-Spine Systems, Inc.201511
+5K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+5K142213Via Spinous Process Fixation SystemSpineology, Inc.20140—
+5K133052Affix (R) Next Gen Spinous Process Plate SystemNuvasive, Inc.201318—
+5K131156Lanx Spinal Fixation SystemLanx, Inc.20131—
+6K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+6K250560BEE HANGMedical GmbH20250—
+6K240699SCARLET® AC-TiSpineart SA20240—
+6K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+6K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+6K234051Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA Posterior Fusion…Spinal Simplicity, LLC20241—
+6K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+6K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+6K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+6K230424Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral…Omnia Medical, LLC20230—
+6K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+6K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+6K201427Trivergent Spinal Fixation SystemBenvenue Medical, Inc.20202—
+6K202309Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty Fixation System, Concero…Zimmer Biomet Spine, Inc.20200—
+6K201006K2M Navigation InstrumentsK2m, Inc.20200—
+6K180153X-spine Cortical Bone Screw SystemX-Spine Systems, Inc.20180—
+6K172469TiLock Modular Spinal SystemGenesys Spine20170—
+6K151727Everest Spinal SystemK2m, Inc.201511—
+7K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+7K253169Duet™ Spinal Fixation SystemBox Spine, LLC20261—
+7K253250Minuteman® G6 MIS Fusion PlateSpinal Simplicity, LLC20250—
+7K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+7K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+7K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+7K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+8K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC20260—
+8K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+8K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—