FDA 510(k)

MP 平面釘無絲 (36BMP000020/MP20)

K 號：K240321 · 2024-10-17

決定日期2024-10-17

產品代碼DZL

諮詢委員會DE

決定相當於

器材摘要

MP Pin flat without thread (36BMP000020/MP20) 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 2024-10-17 under 510(k) number K240321. 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 MP Pin flat without thread (36BMP000020/MP20)?

MP Pin flat without thread (36BMP000020/MP20) is a medical device that received FDA 510(k) clearance on 2024-10-17. The listed applicant is Hager& Meisinger GmbH. The 510(k) number is K240321.

When did MP Pin flat without thread (36BMP000020/MP20) receive FDA 510(k) clearance?

MP Pin flat without thread (36BMP000020/MP20) received FDA 510(k) clearance on 2024-10-17, under 510(k) number K240321.

Who is the listed applicant for MP Pin flat without thread (36BMP000020/MP20)?

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 MP Pin flat without thread (36BMP000020/MP20)?

The FDA product code for MP Pin flat without thread (36BMP000020/MP20) is DZL.

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)K201210微螺釘系統，微螺釘系統基本版 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

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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 GmbH K251569骨釘Osstem Implant Co., Ltd.K243190自訂骨固定/骨增強系統 - PINUstomed Instrumente Ulrich Storz GmbH & Co. KG K233419GBR系統Proimtech Saglik Urunleri Anonim Sirketi K233721KLS Martin 零钻式 MMF 螺釘KLS-Martin L.P.

官方來源

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