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FDA 510(k)

KMTI 髋關節置換系統，Tesera Trabecular Technologies (T3) 骨盂殼系統，多孔骨盂杯系統

K 號：K201660 · 2020-07-16

申請人Kyocera Medical Technologies, Inc.
決定日期2020-07-16
產品代碼OQG
諮詢委員會或
決定相當於

器材摘要

KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System is the device name listed in this FDA 510(k) record. The listed applicant is Kyocera Medical Technologies, Inc.. It received FDA 510(k) clearance on 2020-07-16 under 510(k) number K201660. The device is classified under product code OQG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System?

KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System is a medical device that received FDA 510(k) clearance on 2020-07-16. The listed applicant is Kyocera Medical Technologies, Inc.. The 510(k) number is K201660.

When did KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System receive FDA 510(k) clearance?

KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System received FDA 510(k) clearance on 2020-07-16, under 510(k) number K201660.

Who is the listed applicant for KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System?

FDA 510(k) 記錄將京瓷醫療技術股份有限公司列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System?

The FDA product code for KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System is OQG.

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 Kyocera Medical Technologies, 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。

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相關器械（代碼：OQG）

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。

K202705Prime及DYNASTY® 增材製造殼Microport Orthopedics, Inc.K203472KMTI 髋關節置換系統Kyocera Medical Technologies, Inc.K200328泰莎骨小梁技術公司（T3）骨盂殼系統，多孔骨盂杯系統Kyocera Medical Technologies, Inc.K172651FMP擴充型管線Encore Medical L.P.K171543Renovis外科人工髋關節置換系統Renovis Surgical TechnologiesK173104Klassic HD® 折疊式骨盆插管配E-Link® 聚乙烯，Klassic HD® 低矮型骨盆插管配E-Link® 聚乙烯Total Joint Orthopedics, Inc.

官方來源

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