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FDA 510(k)

三叉II骨盂系統

K 號：K191358 · 2019-10-24

申請人Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics
決定日期2019-10-24
產品代碼LPH
諮詢委員會或
決定相當於

器材摘要

Trident II Acetabular System is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics. It received FDA 510(k) clearance on 2019-10-24 under 510(k) number K191358. 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 Trident II Acetabular System?

Trident II Acetabular System is a medical device that received FDA 510(k) clearance on 2019-10-24. The listed applicant is Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics. The 510(k) number is K191358.

When did Trident II Acetabular System receive FDA 510(k) clearance?

Trident II Acetabular System received FDA 510(k) clearance on 2019-10-24, under 510(k) number K191358.

Who is the listed applicant for Trident II Acetabular System?

The FDA 510(k) record lists Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Trident II Acetabular System?

The FDA product code for Trident II Acetabular System is LPH.

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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：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

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