FDA 510(k)

Trident® II Tritanium® 髖臼蓋及 6.5 mm 低筒身六角螺釘

K 號：K161569 · 2016-10-14

申請人Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics

決定日期2016-10-14

產品代碼LPH

諮詢委員會或

決定相當於

器材摘要

Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws 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 2016-10-14 under 510(k) number K161569. 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 Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws?

Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws is a medical device that received FDA 510(k) clearance on 2016-10-14. The listed applicant is Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics. The 510(k) number is K161569.

When did Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws receive FDA 510(k) clearance?

Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws received FDA 510(k) clearance on 2016-10-14, under 510(k) number K161569.

Who is the listed applicant for Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws?

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 Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws?

The FDA product code for Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws is LPH.

其他以 Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics 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。

K233261全球模組化更換系統 K210893修復解剖殼 K203099鐵人三項PKR系統 K191358三叉II骨盂系統 K182468Trident X3 骨盆植入物，ADM 及 MDM X3 骨盆植入物，Accolade II 髋關節系統 K180612鐵人三項PKR X3 靈骨植入物，Mako X3 聯合覆蓋靈骨植入物

查看所有 9 項裝置 →

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 Biomet K253630Mpact 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 Orthopaedics K243192iNSitu 外側骨盆內襯，iNSitu 髋臥骨柄帶等离子體噴射CPTi塗層Nextstep Arthopedix, LLC K251270Taperloc® 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。