FDA 510(k)

正骨科兒童醫療設備融合板

K 號：K172425 · 2017-12-06

決定日期2017-12-06

產品代碼HRS

諮詢委員會或

決定相當於

器材摘要

OrthoPediatrics Wrist Fusion Plate is the device name listed in this FDA 510(k) record. The listed applicant is Orthopediatrics, Inc.. It received FDA 510(k) clearance on 2017-12-06 under 510(k) number K172425. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the OrthoPediatrics Wrist Fusion Plate?

OrthoPediatrics Wrist Fusion Plate is a medical device that received FDA 510(k) clearance on 2017-12-06. The listed applicant is Orthopediatrics, Inc.. The 510(k) number is K172425.

When did OrthoPediatrics Wrist Fusion Plate receive FDA 510(k) clearance?

OrthoPediatrics Wrist Fusion Plate received FDA 510(k) clearance on 2017-12-06, under 510(k) number K172425.

Who is the listed applicant for OrthoPediatrics Wrist Fusion Plate?

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 Wrist Fusion Plate?

The FDA product code for OrthoPediatrics Wrist Fusion Plate is HRS.

其他以 Orthopediatrics, Inc. 為申請人之記錄

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K172583OrthoPediatrics PediNail 髓內平台

相關器械（代碼：HRS）

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。

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