FDA 510(k)

Master-Pin X (帶絲牙的MP釘針) (36BMP000030 / MP30)

K 號：K250123 · 2025-09-29

決定日期2025-09-29

產品代碼DZL

諮詢委員會DE

決定相當於

器材摘要

Master-Pin X (MP Pin with thread) (36BMP000030 / MP30) 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 2025-09-29 under 510(k) number K250123. 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 Master-Pin X (MP Pin with thread) (36BMP000030 / MP30)?

Master-Pin X (MP Pin with thread) (36BMP000030 / MP30) is a medical device that received FDA 510(k) clearance on 2025-09-29. The listed applicant is Hager& Meisinger GmbH. The 510(k) number is K250123.

When did Master-Pin X (MP Pin with thread) (36BMP000030 / MP30) receive FDA 510(k) clearance?

Master-Pin X (MP Pin with thread) (36BMP000030 / MP30) received FDA 510(k) clearance on 2025-09-29, under 510(k) number K250123.

Who is the listed applicant for Master-Pin X (MP Pin with thread) (36BMP000030 / MP30)?

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 Master-Pin X (MP Pin with thread) (36BMP000030 / MP30)?

The FDA product code for Master-Pin X (MP Pin with thread) (36BMP000030 / MP30) 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。

K240321MP 平面釘無絲 (36BMP000020/MP20)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

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.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 K240321MP 平面釘無絲 (36BMP000020/MP20)Hager& Meisinger GmbH K233721KLS Martin 零钻式 MMF 螺釘KLS-Martin L.P.

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。