FDA 510(k)

FITBONE® 転移與延長系統

K 號：K260146 · 2026-05-19

決定日期2026-05-19

產品代碼HSB

諮詢委員會或

決定相當於

器材摘要

FITBONE® TRANSPORT AND LENGTHENING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Orthofix Srl. It received FDA 510(k) clearance on 2026-05-19 under 510(k) number K260146. 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 FITBONE® TRANSPORT AND LENGTHENING SYSTEM?

FITBONE® TRANSPORT AND LENGTHENING SYSTEM is a medical device that received FDA 510(k) clearance on 2026-05-19. The listed applicant is Orthofix Srl. The 510(k) number is K260146.

When did FITBONE® TRANSPORT AND LENGTHENING SYSTEM receive FDA 510(k) clearance?

FITBONE® TRANSPORT AND LENGTHENING SYSTEM received FDA 510(k) clearance on 2026-05-19, under 510(k) number K260146.

Who is the listed applicant for FITBONE® TRANSPORT AND LENGTHENING SYSTEM?

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 FITBONE® TRANSPORT AND LENGTHENING SYSTEM?

The FDA product code for FITBONE® TRANSPORT AND LENGTHENING SYSTEM is HSB.

其他以 Orthofix Srl 為申請人之記錄

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K253991Fitbone™ 髋臼，FITBONE® 运輸及延長系統，FITBONE® TAA K250112Fitbone™ 髋臼突盤 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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