免責聲明: 本站彙整 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公開資料，僅供一般參考，不構成醫療建議、診斷、治療建議或投資建議。

FDA 510(k)

EXPEDIUM®脊椎系統，EXPEDIUM VERSE®脊椎系統：ALTALYNE™超級桿

K 號：K222473 · 2022-10-13

申請人Medos-International Sarl
決定日期2022-10-13
產品代碼NKB
諮詢委員會或
決定相當於

器材摘要

EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra Rods is the device name listed in this FDA 510(k) record. The listed applicant is Medos-International Sarl. It received FDA 510(k) clearance on 2022-10-13 under 510(k) number K222473. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra Rods?

EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra Rods is a medical device that received FDA 510(k) clearance on 2022-10-13. The listed applicant is Medos-International Sarl. The 510(k) number is K222473.

When did EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra Rods receive FDA 510(k) clearance?

EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra Rods received FDA 510(k) clearance on 2022-10-13, under 510(k) number K222473.

Who is the listed applicant for EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra Rods?

The FDA 510(k) record lists Medos-International Sarl as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra Rods?

The FDA product code for EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra Rods is NKB.

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 Medos-International Sarl 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。

K254157CROSSNAV 體外預處理及間體植入器導航設備K260240和諧導航準備儀器K253249TriALTIS™脊椎系統K243249TriALTIS™脊椎系統K241893CROSSNAV導航啟用儀器和UNAS導航陣列K242042TriALTIS™脊椎系統

查看所有 75 項裝置 →

相關器械（代碼：NKB）

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。

K252139肯特羅斯賓 Viktr-MIS® 椎板螺釘系統Rivarp Medical Pvt., Ltd.K262067iFuse Granite Onyx™ 假骨植入系統SI-BONE, Inc.K262091FRAXION脊椎固定系統Ortler Global Tibbi Gerecler Anonim SirketiK262193RIVA® 後固定系統搭配NanoACTIV表面技術；RIVA® 髋骨結合固定釘搭配NanoACTIV表面技術Xenix MedicalK262828KHEIRON®脊椎固定系統，包括客製化K-RODS.M.A.I.OK260362QUATTRO脊椎系統（開放配置）；QUATTRO-GADGET脊椎系統（MIS配置）MANTIZ Co., Ltd.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。

↑