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SeaSpine Orthopedics Corporation

FDA 510(k) & PMA Approved 器械 — 67 products

器械总数67
类别0
最新FDA决定
类型编号器械名称代码日期操作
510(k) K253420 Admiral ACP系统；Explorer TO系统；Laminoplasty系统；Manta Ray TDF间隔器；Meridian椎间系统；Meridian前板系统；Reef L椎间系统；Reef TO/TA系统；Regatta L侧系统；Regatta L侧板系统；Shoreline ACS椎间系统；Shoreline螺纹TruProfile板；Shoreline RT椎间系统；Vu网格；WaveForm A椎间系统；WaveForm C椎间系统；WaveForm L椎间系统；WaveForm TA椎间系统；WaveForm TO椎间系统MAX2026-07-01 查看
510(k) K250908 维拉塔脊柱固定系统NKB2025-06-18 查看
510(k) K243659 FLASH® 骨突融合工具，IsoTis® 骨突融合工具OLO2025-04-02 查看
510(k) K242273 Cove粘土，OsteoCove粘土MQV2024-09-25 查看
510(k) K241466 Shoreline ACS椎间系统；Shoreline RT椎间系统；Regatta 侧系统；Reef L椎间系统；Reef TO/TA系统；Meridian椎间系统；WaveForm C椎间系统；WaveForm L椎间系统；WaveForm TO椎间系统；WaveForm TA椎间系统；WaveForm A椎间系统MAX2024-06-20 查看
510(k) K240566 Reef L椎间系统；WaveForm L椎间系统MAX2024-04-26 查看
510(k) K232566 NewPort 脊柱系统；Daytona 小身材脊柱系统；Malibu 脊柱系统；Mariner 椎弓根系统：Mariner 外展修订系统；Mariner MIS 椎弓根系统；Mariner 畸形系统；Mariner RDX 系统NKB2024-04-19 查看
510(k) K233694 Meridian椎间系统；WaveForm A椎间系统MAX2024-01-12 查看
510(k) K233414 Shoreline ACS椎间系统；Shoreline RT椎间系统OVE2023-11-28 查看
510(k) K232668 Cove条，OsteoCove条MQV2023-09-27 查看
510(k) K231030 Cove粘土，OsteoCove粘土MQV2023-09-14 查看
510(k) K230486 Cove条MQV2023-08-21 查看
510(k) K220296 Manta Ray TDF SpacerODP2023-02-03 查看
510(k) K222753 SeaSpine 7D导航仪器OLO2022-12-09 查看
510(k) K222732 波形A椎间系统MAX2022-11-07 查看
510(k) K222110 Mariner RDX 系统NKB2022-09-07 查看
510(k) K220711 SeaSpine Meridian 系统，SeaSpine Meridian 前板系统MAX2022-05-10 查看
510(k) K213420 WaveForm L 系统，WaveForm TO 系统，WaveForm TA 系统MAX2022-05-04 查看
510(k) K212904 SeaSpine WaveForm C 椎间系统OVE2021-12-14 查看
510(k) K213359 SeaSpine WaveForm, C 椎间系统OVE2021-12-09 查看
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