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FDA 510(k)

DePuy Synthes (美國) 5.0mm / 7.3mm 压接定位針 – MR 相容，DePuy Synthes 可變角度定位針 – MR 相容，DePuy Synthes 線材固定器 – MR 相容，DePuy Synthes 環繞定位針 – MR 相容

K 號：K172975 · 2018-06-21

申請人Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.
決定日期2018-06-21
產品代碼JDQ
諮詢委員會或
決定相當於

器材摘要

DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins – MR Conditional, DePuy Synthes Variable Angle Positioning Pins – MR Conditional, DePuy Synthes Wire Mount – MR Conditional, DePuy Synthes Cerclage Positioning Pin – MR Conditional is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.. It received FDA 510(k) clearance on 2018-06-21 under 510(k) number K172975. The device is classified under product code JDQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins – MR Conditional, DePuy Synthes Variable Angle Positioning Pins – MR Conditional, DePuy Synthes Wire Mount – MR Conditional, DePuy Synthes Cerclage Positioning Pin – MR Conditional?

DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins – MR Conditional, DePuy Synthes Variable Angle Positioning Pins – MR Conditional, DePuy Synthes Wire Mount – MR Conditional, DePuy Synthes Cerclage Positioning Pin – MR Conditional is a medical device that received FDA 510(k) clearance on 2018-06-21. The listed applicant is Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.. The 510(k) number is K172975.

When did DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins – MR Conditional, DePuy Synthes Variable Angle Positioning Pins – MR Conditional, DePuy Synthes Wire Mount – MR Conditional, DePuy Synthes Cerclage Positioning Pin – MR Conditional receive FDA 510(k) clearance?

DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins – MR Conditional, DePuy Synthes Variable Angle Positioning Pins – MR Conditional, DePuy Synthes Wire Mount – MR Conditional, DePuy Synthes Cerclage Positioning Pin – MR Conditional received FDA 510(k) clearance on 2018-06-21, under 510(k) number K172975.

Who is the listed applicant for DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins – MR Conditional, DePuy Synthes Variable Angle Positioning Pins – MR Conditional, DePuy Synthes Wire Mount – MR Conditional, DePuy Synthes Cerclage Positioning Pin – MR Conditional?

The FDA 510(k) record lists Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins – MR Conditional, DePuy Synthes Variable Angle Positioning Pins – MR Conditional, DePuy Synthes Wire Mount – MR Conditional, DePuy Synthes Cerclage Positioning Pin – MR Conditional?

The FDA product code for DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins – MR Conditional, DePuy Synthes Variable Angle Positioning Pins – MR Conditional, DePuy Synthes Wire Mount – MR Conditional, DePuy Synthes Cerclage Positioning Pin – MR Conditional is JDQ.

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 Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. 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。

K192745德普伊森斯外傷螺釘K181933德普伊森斯消毒容器系統K180310DePuy Synthes 骨折外傷骨科板及釘子K160553DePuy Synthes 4.0 mm 及 5.0 mm 鎖定螺釘 – MR 相容，DePuy Synthes 腕關節融合板 (WFP) – MR 相容，DePuy Synthes 大骨片動態壓縮鎖定 (DCL) 系統 – MR 相容，DePuy Synthes 小骨片動態壓縮鎖定 (DCL) 系統 – MR 相容，DePuy Synthes 模組化腳部系統 – MR 相容，DePuy Synthes T 型板 – MR 相容，DePuy Synthes 三分之一管型板帶頸圈 (OTPC) – MR 相容，DePuy Synthes 不銹鋼 S

相關器械（代碼：JDQ）

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。

K261271Cable-Ready® 線材夾緊系統Pioneer Surgical Technology, Inc.K243905縫合環繞器 – 缝合膠帶GM Dos Reis Industria e Comercio Ltda.K243344Arthrex 纤維膠帶及虎膠帶纏繞縫線；Arthrex 放射不透明纖維膠帶纏繞縫線Arthrex, Inc.K232733Mbrace 線材Medacta International S.A.K233949ACCORD 線路系統Smith & Nephew, Inc.K232986VariTrax 胸骨環固定系統Circumfix Solutions, Inc.

官方來源

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