免責聲明: 本站彙整 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公開資料，僅供一般參考，不構成醫療建議、診斷、治療建議或投資建議。

FDA 510(k)

Klassic 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

K 號：K173104 · 2017-10-27

申請人Total Joint Orthopedics, Inc.
決定日期2017-10-27
產品代碼OQG
諮詢委員會或
決定相當於

器材摘要

Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert with E-Link® Poly is the device name listed in this FDA 510(k) record. The listed applicant is Total Joint Orthopedics, Inc.. It received FDA 510(k) clearance on 2017-10-27 under 510(k) number K173104. 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 Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert with E-Link® Poly?

Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert with E-Link® Poly is a medical device that received FDA 510(k) clearance on 2017-10-27. The listed applicant is Total Joint Orthopedics, Inc.. The 510(k) number is K173104.

When did Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert with E-Link® Poly receive FDA 510(k) clearance?

Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert with E-Link® Poly received FDA 510(k) clearance on 2017-10-27, under 510(k) number K173104.

Who is the listed applicant for Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert with E-Link® Poly?

FDA 510(k) 記錄將 Total Joint Orthopedics, Inc. 列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert with E-Link® Poly?

The FDA product code for Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert with E-Link® Poly 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 Total Joint Orthopedics, 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。

K261734Klassic感染間隔系統K220483Platform® 髋臼系統K211877Klassic 適合膝關節系統K211602Klassic 適合膝關節系統K202740Klassic膝關節系統胫骨插板，PS-MaxK183596Klassic膝關節系統 - Klassic膝關節 PS-Post大腿；Klassic膝關節胫骨植入體，PS-Post，標準多聚物；Klassic膝關節胫骨植入體，PS-Post，E-Link多聚物

查看所有 12 項裝置 →

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.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 Technologies

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。

↑