免責聲明: 本站彙整 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公開資料，僅供一般參考，不構成醫療建議、診斷、治療建議或投資建議。

FDA 510(k)

微螺釘系統，微螺釘系統基本版

K 號：K201210 · 2021-10-08

申請人Hager& Meisinger GmbH
決定日期2021-10-08
產品代碼DZL
諮詢委員會DE
決定相當於

器材摘要

The Micro Screw System, Micro Screw System Basic is the device name listed in this FDA 510(k) record. The listed applicant is Hager& Meisinger GmbH. It received FDA 510(k) clearance on 2021-10-08 under 510(k) number K201210. The device is classified under product code DZL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the The Micro Screw System, Micro Screw System Basic?

The Micro Screw System, Micro Screw System Basic is a medical device that received FDA 510(k) clearance on 2021-10-08. The listed applicant is Hager& Meisinger GmbH. The 510(k) number is K201210.

When did The Micro Screw System, Micro Screw System Basic receive FDA 510(k) clearance?

The Micro Screw System, Micro Screw System Basic received FDA 510(k) clearance on 2021-10-08, under 510(k) number K201210.

Who is the listed applicant for The Micro Screw System, Micro Screw System Basic?

The FDA 510(k) record lists Hager& Meisinger GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for The Micro Screw System, Micro Screw System Basic?

The FDA product code for The Micro Screw System, Micro Screw System Basic is DZL.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Hager& Meisinger GmbH 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。

K250123Master-Pin X (帶絲牙的MP釘針) (36BMP000030 / MP30)K240321MP 平面釘無絲 (36BMP000020/MP20)K173819MyPlant II 偽裝系統K180360OKTAGON 嵌入系統K170287牙齒植體 OKTAGON 骨水平針狹設計K162073牙齒植體OKTAGON組織層級與骨層級

查看所有 8 項裝置 →

相關器械（代碼：DZL）

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。

K254286導骨再生系統DentalMaster(Xiamen)Medical Technology Co., Ltd.K250123Master-Pin X (帶絲牙的MP釘針) (36BMP000030 / MP30)Hager& Meisinger GmbHK251569骨釘Osstem Implant Co., Ltd.K243190自訂骨固定/骨增強系統 - PINUstomed Instrumente Ulrich Storz GmbH & Co. KGK233419GBR系統Proimtech Saglik Urunleri Anonim SirketiK240321MP 平面釘無絲 (36BMP000020/MP20)Hager& Meisinger GmbH

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。

↑