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FDA 510(k)

NCB®多軸固定板系統；NCB®人工關節股骨板系統；NCB®電纜按鈕；NCB®直窄軸板

K 號：K241754 · 2024-08-15

申請人Zimmer Switzerland Manufacturing GmbH
決定日期2024-08-15
產品代碼HRS
諮詢委員會或
決定相當於

器材摘要

NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate System; NCB® Cable Button; NCB® Straight Narrow Shaft Plate is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer Switzerland Manufacturing GmbH. It received FDA 510(k) clearance on 2024-08-15 under 510(k) number K241754. 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 NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate System; NCB® Cable Button; NCB® Straight Narrow Shaft Plate?

NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate System; NCB® Cable Button; NCB® Straight Narrow Shaft Plate is a medical device that received FDA 510(k) clearance on 2024-08-15. The listed applicant is Zimmer Switzerland Manufacturing GmbH. The 510(k) number is K241754.

When did NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate System; NCB® Cable Button; NCB® Straight Narrow Shaft Plate receive FDA 510(k) clearance?

NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate System; NCB® Cable Button; NCB® Straight Narrow Shaft Plate received FDA 510(k) clearance on 2024-08-15, under 510(k) number K241754.

Who is the listed applicant for NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate System; NCB® Cable Button; NCB® Straight Narrow Shaft Plate?

The FDA 510(k) record lists Zimmer Switzerland Manufacturing GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate System; NCB® Cable Button; NCB® Straight Narrow Shaft Plate?

The FDA product code for NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate System; NCB® Cable Button; NCB® Straight Narrow Shaft Plate 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 Zimmer Switzerland Manufacturing GmbH 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。

K253749Affixus® 自然釘® 近端上臂系統K231114Zimmer® 自然指甲® 系統頭骨脊髓釘；Affixus® 自然指甲® 肱骨釘系統K212129Persona® 預設膝關節系統

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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