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Spinal Elements, Inc.

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

器械总数24
类别0
最新FDA决定
类型编号器械名称代码日期操作
510(k) K260506 Ventana® P/T 腰椎椎间融合系统MAX2026-05-15 查看
510(k) K253559 Ventana™ A 前路腰椎椎间融合系统OVD2026-02-25 查看
510(k) K250773 Luna® Ti椎间融合系统MAX2026-02-04 查看
510(k) K242527 Karma®固定系统MRW2025-05-21 查看
510(k) K243916 Primus Spinal Fixation SystemNKB2025-02-21 查看
510(k) K231593 Sapphire X3 颈前板系统KWQ2023-08-02 查看
510(k) K231252 Ventana™ L 脊柱系统MAX2023-06-30 查看
510(k) K222833 Ventana™ C 脊柱系统ODP2023-05-19 查看
510(k) K222516 Mercury® II脊柱系统NKB2022-12-01 查看
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 查看
510(k) K203254 Lucent 3D脊柱系统MAX2021-03-26 查看
510(k) K202298 Lucent XP, Lucent XP CurvedMAX2020-12-22 查看
510(k) K201029 Sapphire® 脊柱系统,Sapphire X 颈前板脊柱系统KWQ2020-06-17 查看
510(k) K190881 Spinal Elements 导航工具OLO2019-12-19 查看
510(k) K191576 Mercury®脊柱系统,Overwatch®脊柱系统NKB2019-09-16 查看
510(k) K190289 Karma®固定系统OWI2019-04-03 查看
510(k) K182584 Lucent® XPMAX2018-12-10 查看
510(k) K181837 Spinal Elements Ti-Bond 镀层设备MAX2018-11-02 查看
510(k) K180728 Spinal Elements Cerclage 系统OWI2018-09-06 查看
510(k) K172967 Mercury®脊柱系统NKB2018-04-10 查看
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