FDA 510(k)

DynaNail TTC 融合系統

K 號：K171376 · 2017-11-02

決定日期2017-11-02

產品代碼HSB

諮詢委員會或

決定相當於

器材摘要

DynaNail TTC Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is MedShape, Inc.. It received FDA 510(k) clearance on 2017-11-02 under 510(k) number K171376. 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 DynaNail TTC Fusion System?

DynaNail TTC Fusion System is a medical device that received FDA 510(k) clearance on 2017-11-02. The listed applicant is MedShape, Inc.. The 510(k) number is K171376.

When did DynaNail TTC Fusion System receive FDA 510(k) clearance?

DynaNail TTC Fusion System received FDA 510(k) clearance on 2017-11-02, under 510(k) number K171376.

Who is the listed applicant for DynaNail TTC Fusion System?

FDA 510(k) 記錄將 MedShape, 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 DynaNail TTC Fusion System?

The FDA product code for DynaNail TTC Fusion System is HSB.

其他以 MedShape, 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。

K260995DynaNail螺旋®固定系統 K254110DynaNail Mini；DynaNail Hybrid；DynaNail Helix；DynaClip；DynaClip Forte；DynaClip Delta；DynaClip Quattro K250628DynaNail TTC 融合系統 K240530DynaNail Mini 縮窄混合型 K220812DynaClip® 骨釘 K203595DynaFuse 固定系統

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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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