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FDA 510(k)

CSM 潜沉3-L 假體系統

K 號：K173141 · 2018-09-19

申請人Csm Implant
決定日期2018-09-19
產品代碼DZE
諮詢委員會DE
決定相當於

器材摘要

CSM Submerged3-L Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Csm Implant. It received FDA 510(k) clearance on 2018-09-19 under 510(k) number K173141. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CSM Submerged3-L Implant System?

CSM Submerged3-L Implant System is a medical device that received FDA 510(k) clearance on 2018-09-19. The listed applicant is Csm Implant. The 510(k) number is K173141.

When did CSM Submerged3-L Implant System receive FDA 510(k) clearance?

CSM Submerged3-L Implant System received FDA 510(k) clearance on 2018-09-19, under 510(k) number K173141.

Who is the listed applicant for CSM Submerged3-L Implant System?

The FDA 510(k) record lists Csm Implant as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CSM Submerged3-L Implant System?

The FDA product code for CSM Submerged3-L Implant System is DZE.

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

相關器械（代碼：DZE）

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。

K261392三活牙植體系統Paragon Implant Mfg., LLCK260463ZEROS 齿科植體系統Zeros Co., Ltd.K251188UNIQA® 齿科植體系統Uniqa Dental, Ltd.K251232MegaGen 遺傳子顎骨牙植體系統Megagen Implant Co., Ltd.K250806牙齒植體系統A.B. Dental Devices , Ltd.K260006INOS系統Inosys, Inc.

官方來源

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