FDA 510(k)

OrthoPediatrics PediNail 髓內平台

K 號：K172583 · 2018-05-10

決定日期2018-05-10

產品代碼HSB

諮詢委員會或

決定相當於

器材摘要

OrthoPediatrics PediNail Intramedullary Platform is the device name listed in this FDA 510(k) record. The listed applicant is Orthopediatrics, Inc.. It received FDA 510(k) clearance on 2018-05-10 under 510(k) number K172583. 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 OrthoPediatrics PediNail Intramedullary Platform?

OrthoPediatrics PediNail Intramedullary Platform is a medical device that received FDA 510(k) clearance on 2018-05-10. The listed applicant is Orthopediatrics, Inc.. The 510(k) number is K172583.

When did OrthoPediatrics PediNail Intramedullary Platform receive FDA 510(k) clearance?

OrthoPediatrics PediNail Intramedullary Platform received FDA 510(k) clearance on 2018-05-10, under 510(k) number K172583.

Who is the listed applicant for OrthoPediatrics PediNail Intramedullary Platform?

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

What is the FDA product code for OrthoPediatrics PediNail Intramedullary Platform?

The FDA product code for OrthoPediatrics PediNail Intramedullary Platform is HSB.

其他以 Orthopediatrics, 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。

K172425正骨科兒童醫療設備融合板

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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