FDA 510(k)

泰莎骨小梁技術公司（T3）骨盂殼系統，多孔骨盂杯系統

K 號：K200328 · 2020-03-11

決定日期2020-03-11

產品代碼OQG

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器材摘要

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 2020-03-11 under 510(k) number K200328. 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 Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System?

Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System is a medical device that received FDA 510(k) clearance on 2020-03-11. The listed applicant is Kyocera Medical Technologies, Inc.. The 510(k) number is K200328.

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

Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System received FDA 510(k) clearance on 2020-03-11, under 510(k) number K200328.

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

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

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。

K261353泰瑟拉-K 前腰椎間融合（ALIF）系統；泰瑟拉-K XL 系統；腰椎固定系統 K242928泰瑟拉-k SC 系統 K242045初始T3骨盂半球形殼系統 K242771泰瑟拉-k PL系統及泰瑟拉-k XL系統 K243295初始膝關節系統 K243015Skyway前方颈椎板系統

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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.K201660KMTI 髋關節置換系統，Tesera Trabecular Technologies (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 Technologies K173104Klassic 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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