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FDA 510(k)

穩定-L獨立腰椎間系統，穩定-C腰椎間系統

K 號：K232530 · 2023-09-18

申請人Nexus Spine, LLC
決定日期2023-09-18
產品代碼OVD
諮詢委員會或
決定相當於

器材摘要

Stable-L Standalone Lumbar Interbody System, Stable-C Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is Nexus Spine, LLC. It received FDA 510(k) clearance on 2023-09-18 under 510(k) number K232530. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Stable-L Standalone Lumbar Interbody System, Stable-C Interbody System?

Stable-L Standalone Lumbar Interbody System, Stable-C Interbody System is a medical device that received FDA 510(k) clearance on 2023-09-18. The listed applicant is Nexus Spine, LLC. The 510(k) number is K232530.

When did Stable-L Standalone Lumbar Interbody System, Stable-C Interbody System receive FDA 510(k) clearance?

Stable-L Standalone Lumbar Interbody System, Stable-C Interbody System received FDA 510(k) clearance on 2023-09-18, under 510(k) number K232530.

Who is the listed applicant for Stable-L Standalone Lumbar Interbody System, Stable-C Interbody System?

The FDA 510(k) record lists Nexus Spine, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Stable-L Standalone Lumbar Interbody System, Stable-C Interbody System?

The FDA product code for Stable-L Standalone Lumbar Interbody System, Stable-C Interbody System is OVD.

相關臨床試驗

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Nexus Spine, LLC 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K243934穩定-L 腰椎間盤系統K241467穩定-C 間體系統K233375Tranquil-L 間隙系統K240416Tranquil-C 間隙系統K233234PressON脊椎固定系統K231486穩定-L 独立腰椎間融合系統

查看所有 16 項裝置 →

相關器械（代碼：OVD）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K262025Innovasis AxTiHA® 独立式 ALIF 系統；Innovasis TxTiHA® IBF 系統；Innovasis HAtetracell®-C 鈦金屬頸椎 IBF 系統INNO Holdings Inc. DBA InnovasisK261408SABER-XA 系統Elevation SpineK261809Interwedge® 独立側邊架Foundation Surgical GroupK261353泰瑟拉-K 前腰椎間融合（ALIF）系統；泰瑟拉-K XL 系統；腰椎固定系統Kyocera Medical Technologies, Inc.K260810Anteralign LS 盖板Tyber Medical, LLCK254202MectaLIF 3D金屬前臍Medacta International S.A.

官方來源

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