FDA 510(k)

Fitbone™ 髋臼突盤

K 號：K250112 · 2025-04-10

決定日期2025-04-10

產品代碼HSB

諮詢委員會或

決定相當於

器材摘要

FitboneTM Trochanteric is the device name listed in this FDA 510(k) record. The listed applicant is Orthofix Srl. It received FDA 510(k) clearance on 2025-04-10 under 510(k) number K250112. 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 FitboneTM Trochanteric?

FitboneTM Trochanteric is a medical device that received FDA 510(k) clearance on 2025-04-10. The listed applicant is Orthofix Srl. The 510(k) number is K250112.

When did FitboneTM Trochanteric receive FDA 510(k) clearance?

FitboneTM Trochanteric received FDA 510(k) clearance on 2025-04-10, under 510(k) number K250112.

Who is the listed applicant for FitboneTM Trochanteric?

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

What is the FDA product code for FitboneTM Trochanteric?

The FDA product code for FitboneTM Trochanteric is HSB.

其他以 Orthofix Srl 為申請人之記錄

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K260146FITBONE® 転移與延長系統 K253991Fitbone™ 髋臼，FITBONE® 运輸及延長系統，FITBONE® TAA K242270正骨科Next平台系統 K242861TrueLok Elevate K233867Fitbone 髋臼突盤 K232648RODEO 選擇式釘子

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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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