DJO 骨盆系統
K 號：K190057 · 2019-06-07
廣告
器材摘要
DJO Acetabular System is the device name listed in this FDA 510(k) record. The listed applicant is Encore Medical L.P.. It received FDA 510(k) clearance on 2019-06-07 under 510(k) number K190057. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the DJO Acetabular System?
DJO Acetabular System is a medical device that received FDA 510(k) clearance on 2019-06-07. The listed applicant is Encore Medical L.P.. The 510(k) number is K190057.
When did DJO Acetabular System receive FDA 510(k) clearance?
DJO Acetabular System received FDA 510(k) clearance on 2019-06-07, under 510(k) number K190057.
Who is the listed applicant for DJO Acetabular System?
The FDA 510(k) record lists Encore Medical L.P. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for DJO Acetabular System?
The FDA product code for DJO Acetabular System is LPH.
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。
其他以 Encore Medical L.P. 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。
相關器械（代碼：LPH）
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。
K261453G7® 髋臼系統Zimmer BiometK253630Mpact 3D金屬泡沫Medacta International S.A.K254043TRIVANCE™ 髋關節柄Globus Medical, Inc.K261624Omnifit® 20°系列I植入物；Omnifit® Crossfire® 10°系列II植入物；限制性 acetabular 植入物；Trident® Crossfire® 0°聚乙烯植入物；Trident® Crossfire® 10°聚乙烯植入物；System 12 Crossfire® 10°植入物；Trident® 0°限制性 acetabular 植入物；Trident® 限制性 acetabular 线圈；Trident® 全聚乙烯限制性 acetabular 植入物；Crossfire® 偏心植入物 10°；Artisan® 骨栓；UHR® 大頭雙極組件Howmedica Osteonics Corp., Dba Stryker OrthopaedicsK243192iNSitu 外側骨盆內襯，iNSitu 髋臥骨柄帶等离子體噴射CPTi塗層Nextstep Arthopedix, LLCK251270Taperloc® 完整股骨柄Biomet, Inc.
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。
廣告