510(k) Report

Devices descending from K031175

928 later devices reach Click'x Monoaxial Screws and Hooks through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+9K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+9K211306LabyrinthZavation Medical Products, LLC20213—
+9K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+9K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+9K180226TREND II Spinal Fixation System- STEP SeriesPaonan Biotech Co., Ltd.20181—
+9K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+9K180458FOCUS Pedicle Screw SystemNvision Biomedical Technologies, LLC20181—
+9K180324Patriot Spinal Fixation SystemValorus Spine20180—
+9K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+9K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+10K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+10K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+10K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+10K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+10K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+10K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+10K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+10K203452Nano FortiFix® SystemNanovis, LLC20200—
+10K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+11K250769Dakota LP SystemPrecision Spine, Inc.20250—
+11K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+11K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+11K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+11K230329F3D Interbody SystemCorelink, LLC20230—
+12K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+12K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+13K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—