FDA 510(k)

塔隆遠端固定肱骨釘

K 號：K173255 · 2018-02-22

申請人Orthopedic Designs North America, Inc.

決定日期2018-02-22

產品代碼HSB

諮詢委員會或

決定相當於

器材摘要

Talon DistalFix Humeral Nail is the device name listed in this FDA 510(k) record. The listed applicant is Orthopedic Designs North America, Inc.. It received FDA 510(k) clearance on 2018-02-22 under 510(k) number K173255. 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 Talon DistalFix Humeral Nail?

Talon DistalFix Humeral Nail is a medical device that received FDA 510(k) clearance on 2018-02-22. The listed applicant is Orthopedic Designs North America, Inc.. The 510(k) number is K173255.

When did Talon DistalFix Humeral Nail receive FDA 510(k) clearance?

Talon DistalFix Humeral Nail received FDA 510(k) clearance on 2018-02-22, under 510(k) number K173255.

Who is the listed applicant for Talon DistalFix Humeral Nail?

The FDA 510(k) record lists Orthopedic Designs North America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Talon DistalFix Humeral Nail?

The FDA product code for Talon DistalFix Humeral Nail is HSB.

其他以 Orthopedic Designs North America, Inc. 為申請人之記錄

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K210146針筒壓力設備系統

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.

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