FDA 510(k)

Affixus 胫骨釘系統 - 4mm 螺釘

K 號：K243907 · 2025-02-12

決定日期2025-02-12

產品代碼HSB

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器材摘要

Affixus Tibial Nailing System - 4mm screws is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer, Inc.. It received FDA 510(k) clearance on 2025-02-12 under 510(k) number K243907. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Affixus Tibial Nailing System - 4mm screws?

Affixus Tibial Nailing System - 4mm screws is a medical device that received FDA 510(k) clearance on 2025-02-12. The listed applicant is Zimmer, Inc.. The 510(k) number is K243907.

When did Affixus Tibial Nailing System - 4mm screws receive FDA 510(k) clearance?

Affixus Tibial Nailing System - 4mm screws received FDA 510(k) clearance on 2025-02-12, under 510(k) number K243907.

Who is the listed applicant for Affixus Tibial Nailing System - 4mm screws?

FDA 510(k) 記錄將 Zimmer, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Affixus Tibial Nailing System - 4mm screws?

The FDA product code for Affixus Tibial Nailing System - 4mm screws is HSB.

其他以 Zimmer, Inc. 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。

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相關器械（代碼：HSB）

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。

K261345兒童釘針平台髋骨OrthoPediatrics Corp.K261481Pangea 髋骨重建系統Stryker GmbH K253080AND 医療股骨釘系統 (PFNA01); AND 医療股骨釘系統 (PFNA02)Suzhou and Science & Technology Development Corp.K261651Precice™ Max 系統及 Precice™ 腳踝挽救系統NuVasive Specialized Orthopedics K253155富麗金屬可鎖定內骨髓釘系統Beijing Fule Science & Technology Development Co., Ltd.K253046HERA 開合式硬脊釘系統ZheJiang Decans Medical Devices Co., Ltd.

官方來源

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