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FDA 510(k)

比奧米特微固定 SternaLock 360 胸骨固定系統

K 號：K163007 · 2016-11-23

申請人Biomet Microfixation
決定日期2016-11-23
產品代碼HRS
諮詢委員會或
決定相當於

器材摘要

Biomet Microfixation SternaLock 360 Sternal Closure System is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Microfixation. It received FDA 510(k) clearance on 2016-11-23 under 510(k) number K163007. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Biomet Microfixation SternaLock 360 Sternal Closure System?

Biomet Microfixation SternaLock 360 Sternal Closure System is a medical device that received FDA 510(k) clearance on 2016-11-23. The listed applicant is Biomet Microfixation. The 510(k) number is K163007.

When did Biomet Microfixation SternaLock 360 Sternal Closure System receive FDA 510(k) clearance?

Biomet Microfixation SternaLock 360 Sternal Closure System received FDA 510(k) clearance on 2016-11-23, under 510(k) number K163007.

Who is the listed applicant for Biomet Microfixation SternaLock 360 Sternal Closure System?

The FDA 510(k) record lists Biomet Microfixation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Biomet Microfixation SternaLock 360 Sternal Closure System?

The FDA product code for Biomet Microfixation SternaLock 360 Sternal Closure System is HRS.

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 Biomet Microfixation 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。

K261002Pectus Blu 系統K241709Pectus Blu 支援條系統K2231992.1 x 255mm 間隙，22mm StopK212782SternaLock 胸骨固定系統K212608RibFix 胸部固定系統K213712胸骨支撐條系統

查看所有 13 項裝置 →

相關器械（代碼：HRS）

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。

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官方來源

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