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SeaSpine Orthopedics Corporation

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

器材總數67
類別0
最新 FDA 裁決
類型編號器材名稱代碼日期操作
510(k) K253420 Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody SystemMAX2026-07-01 查看
510(k) K250908 維拉塔脊椎固定系統NKB2025-06-18 查看
510(k) K243659 FLASH™ 髋節融合儀器，IsoTis® 髋節融合儀器OLO2025-04-02 查看
510(k) K242273 Cove 黏土，OsteoCove 黏土MQV2024-09-25 查看
510(k) K241466 Shoreline ACS 內固定系統；Shoreline RT 內固定系統；Regatta 旁路系統；Reef L 內固定系統；Reef TO/TA 系統；Meridian 內固定系統；WaveForm C 內固定系統；WaveForm L 內固定系統；WaveForm TO 內固定系統；WaveForm TA 內固定系統；WaveForm A 內固定系統MAX2024-06-20 查看
510(k) K240566 Reef L 間體系統；WaveForm L 間體系統MAX2024-04-26 查看
510(k) K232566 NewPort脊椎系統；Daytona小型身材脊椎系統；Malibu脊椎系統；Mariner椎板螺釘系統：Mariner外擴修復系統；Mariner MIS椎板螺釘系統；Mariner畸形系統；Mariner RDX系統NKB2024-04-19 查看
510(k) K233694 美麗安內固定系統；波形A內固定系統MAX2024-01-12 查看
510(k) K233414 Shoreline ACS間隔系統；Shoreline RT間隔系統OVE2023-11-28 查看
510(k) K232668 Cove Strip，骨康Cove StripMQV2023-09-27 查看
510(k) K231030 Cove 黏土，OsteoCove 黏土MQV2023-09-14 查看
510(k) K230486 Cove StripMQV2023-08-21 查看
510(k) K220296 瑪坦雷TDF間隔器ODP2023-02-03 查看
510(k) K222753 SeaSpine 7D導航儀器OLO2022-12-09 查看
510(k) K222732 波型A間隙系統MAX2022-11-07 查看
510(k) K222110 航海者RDX系統NKB2022-09-07 查看
510(k) K220711 SeaSpine Meridian 系統，SeaSpine Meridian 前板系統MAX2022-05-10 查看
510(k) K213420 波型L系統，波型TO系統，波型TA系統MAX2022-05-04 查看
510(k) K212904 SeaSpine WaveForm C 間隙系統OVE2021-12-14 查看
510(k) K213359 SeaSpine WaveForm, C間隙系統OVE2021-12-09 查看
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