FDA 510(k)

Affixus 胫骨和前向股骨釘系統

K 號：K241651 · 2024-09-26

決定日期2024-09-26

產品代碼HSB

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決定相當於

器材摘要

Affixus Tibial and Antegrade Femoral Nailing System is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer, Inc.. It received FDA 510(k) clearance on 2024-09-26 under 510(k) number K241651. 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 and Antegrade Femoral Nailing System?

Affixus Tibial and Antegrade Femoral Nailing System is a medical device that received FDA 510(k) clearance on 2024-09-26. The listed applicant is Zimmer, Inc.. The 510(k) number is K241651.

When did Affixus Tibial and Antegrade Femoral Nailing System receive FDA 510(k) clearance?

Affixus Tibial and Antegrade Femoral Nailing System received FDA 510(k) clearance on 2024-09-26, under 510(k) number K241651.

Who is the listed applicant for Affixus Tibial and Antegrade Femoral Nailing System?

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 and Antegrade Femoral Nailing System?

The FDA product code for Affixus Tibial and Antegrade Femoral Nailing System 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。

K262955OsseoFit無柄肩部系統 K261683Augment 偏心儀器系統 K260831Z1 髋關節系統 K251840齊默® 佩森娜® 適合個人化膝關節系統 K260182Avenir® Müller 植入物；Avenir Complete™ 髋關節系統 K253592Zimmer Biomet 反向肩蓋假體（Alliance 肱骨承重環，Identity 肱骨托盤，全面性反向肱骨托盤，全面性反向 32mm 髋球和適配器）

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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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