FDA 510(k)

正畸固定螺釘 [智慧夾具迷你螺釘]

K 號：K191041 · 2020-08-28

決定日期2020-08-28

產品代碼OAT

諮詢委員會DE

決定相當於

器材摘要

Orthodontic Fixation Screw [Smart Anchor Miniscrew] is the device name listed in this FDA 510(k) record. The listed applicant is Gni Co., Ltd.. It received FDA 510(k) clearance on 2020-08-28 under 510(k) number K191041. The device is classified under product code OAT. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Orthodontic Fixation Screw [Smart Anchor Miniscrew]?

Orthodontic Fixation Screw [Smart Anchor Miniscrew] is a medical device that received FDA 510(k) clearance on 2020-08-28. The listed applicant is Gni Co., Ltd.. The 510(k) number is K191041.

When did Orthodontic Fixation Screw [Smart Anchor Miniscrew] receive FDA 510(k) clearance?

Orthodontic Fixation Screw [Smart Anchor Miniscrew] received FDA 510(k) clearance on 2020-08-28, under 510(k) number K191041.

Who is the listed applicant for Orthodontic Fixation Screw [Smart Anchor Miniscrew]?

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

What is the FDA product code for Orthodontic Fixation Screw [Smart Anchor Miniscrew]?

The FDA product code for Orthodontic Fixation Screw [Smart Anchor Miniscrew] is OAT.

其他以 Gni Co., Ltd. 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。

K201410威尼斯夾具，玫瑰夾具 K182672ROSA 準備架

相關器械（代碼：OAT）

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。

K260268OrthoEasy Pal；OrthoEasy Pal 長頸版Bernhard Förster GmbH (Bernhard Foerster Ltd.)K242944萊昂正畸植入物TAD（臨時固位裝置）Leone S.P.A.K231502迷你螺釘Proimtech Saglik Urunleri Anonim Sirketi K231913T-FITTechwin Co., Ltd.K222245ACR 螺釘系統Biomaterials Korea, Inc.K202163Mico One 正畸螺釘Ze Fang Technology Co., Ltd.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。