FDA 510(k)

I.T.S. INS 近端股骨釘

K 號：K233134 · 2024-02-12

決定日期2024-02-12

產品代碼HSB

諮詢委員會或

決定相當於

器材摘要

I.T.S. INS Proximal Femur Nail is the device name listed in this FDA 510(k) record. The listed applicant is I.T.S. GmbH. It received FDA 510(k) clearance on 2024-02-12 under 510(k) number K233134. 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 I.T.S. INS Proximal Femur Nail?

I.T.S. INS Proximal Femur Nail is a medical device that received FDA 510(k) clearance on 2024-02-12. The listed applicant is I.T.S. GmbH. The 510(k) number is K233134.

When did I.T.S. INS Proximal Femur Nail receive FDA 510(k) clearance?

I.T.S. INS Proximal Femur Nail received FDA 510(k) clearance on 2024-02-12, under 510(k) number K233134.

Who is the listed applicant for I.T.S. INS Proximal Femur Nail?

The FDA 510(k) record lists I.T.S. GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for I.T.S. INS Proximal Femur Nail?

The FDA product code for I.T.S. INS Proximal Femur Nail is HSB.

其他以 I.T.S. GmbH 為申請人之記錄

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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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