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Spinal Elements, Inc.

FDA 510(k) & PMA Approved Devices — 24 products

Total Devices24
Categories10
Latest FDA decision2026-05-15
TypeNumberDevice NameCodeDateActions
510(k) K260506 Ventana® P/T Lumbar Interbody SystemMAX2026-05-15 View
510(k) K253559 Ventana™ A Anterior Lumbar Interbody SystemOVD2026-02-25 View
510(k) K250773 Luna® Ti Interbody Fusion SystemMAX2026-02-04 View
510(k) K242527 The Karma® Fixation SystemMRW2025-05-21 View
510(k) K243916 Primus Spinal Fixation SystemNKB2025-02-21 View
510(k) K231593 Sapphire X3 Anterior Cervical Plate SystemKWQ2023-08-02 View
510(k) K231252 Ventana™ L Spinal SystemMAX2023-06-30 View
510(k) K222833 Ventana™ C Spinal SystemODP2023-05-19 View
510(k) K222516 Mercury® II Spinal SystemNKB2022-12-01 View
510(k) K210044 Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System, Ceres-C Spinal System, Omega XP Spinal SystemMAX2021-06-30 View
510(k) K203254 Lucent 3D Spinal SystemMAX2021-03-26 View
510(k) K202298 Lucent XP, Lucent XP CurvedMAX2020-12-22 View
510(k) K201029 Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal SystemKWQ2020-06-17 View
510(k) K190881 Spinal Elements Navigated InstrumentsOLO2019-12-19 View
510(k) K191576 Mercury® Spinal System, Overwatch® Spinal SystemNKB2019-09-16 View
510(k) K190289 Karma® Fixation SystemOWI2019-04-03 View
510(k) K182584 Lucent® XPMAX2018-12-10 View
510(k) K181837 Spinal Elements Ti-Bond coated devicesMAX2018-11-02 View
510(k) K180728 Spinal Elements Cerclage SystemOWI2018-09-06 View
510(k) K172967 Mercury® Spinal SystemNKB2018-04-10 View

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