FDA 510(k)

Precice® 靈骨救護系統

K 號：K200430 · 2020-09-16

申請人Nuvasive Specialized Orthopedics, Inc.

決定日期2020-09-16

產品代碼HSB

諮詢委員會或

決定相當於

器材摘要

Precice® Ankle Salvage System is the device name listed in this FDA 510(k) record. The listed applicant is Nuvasive Specialized Orthopedics, Inc.. It received FDA 510(k) clearance on 2020-09-16 under 510(k) number K200430. 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 Precice® Ankle Salvage System?

Precice® Ankle Salvage System is a medical device that received FDA 510(k) clearance on 2020-09-16. The listed applicant is Nuvasive Specialized Orthopedics, Inc.. The 510(k) number is K200430.

When did Precice® Ankle Salvage System receive FDA 510(k) clearance?

Precice® Ankle Salvage System received FDA 510(k) clearance on 2020-09-16, under 510(k) number K200430.

Who is the listed applicant for Precice® Ankle Salvage System?

The FDA 510(k) record lists Nuvasive Specialized Orthopedics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Precice® Ankle Salvage System?

The FDA product code for Precice® Ankle Salvage System is HSB.

其他以 Nuvasive Specialized Orthopedics, Inc. 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.

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