FDA 510(k)

Stryker 骨科髋關節系統標籤更新

K 號：K233498 · 2023-12-21

申請人Howmedica Osteonics Corp., Dba Stryker Orthopaedics

決定日期2023-12-21

產品代碼LPH

諮詢委員會或

決定相當於

器材摘要

Stryker Orthopaedics Hip Systems Labeling Update is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Osteonics Corp., Dba Stryker Orthopaedics. It received FDA 510(k) clearance on 2023-12-21 under 510(k) number K233498. 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 Stryker Orthopaedics Hip Systems Labeling Update?

Stryker Orthopaedics Hip Systems Labeling Update is a medical device that received FDA 510(k) clearance on 2023-12-21. The listed applicant is Howmedica Osteonics Corp., Dba Stryker Orthopaedics. The 510(k) number is K233498.

When did Stryker Orthopaedics Hip Systems Labeling Update receive FDA 510(k) clearance?

Stryker Orthopaedics Hip Systems Labeling Update received FDA 510(k) clearance on 2023-12-21, under 510(k) number K233498.

Who is the listed applicant for Stryker Orthopaedics Hip Systems Labeling Update?

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

What is the FDA product code for Stryker Orthopaedics Hip Systems Labeling Update?

The FDA product code for Stryker Orthopaedics Hip Systems Labeling Update is LPH.

其他以 Howmedica Osteonics Corp., Dba 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。

K261898Triathlon® 過膝系統；Triathlon® 開合膝關節系統；Scorpio® 全膝系統 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 K253637Triathlon® 全膝系統 - Triathlon® X3® 中間穩定胫骨承插件 K252898Triathlon® Tritanium® 非對稱膝蓋；Triathlon® 對稱膝蓋；Triathlon® 對稱膝蓋；Triathlon® 非對稱膝蓋；Scorpio® 適用型圓頂膝蓋；Triathlon® 鍵盤緩震器 K252044Triathlon® 全膝系統 - Triathlon® 金屬股骨组件 K251665Triathlon® 開合膝關節系統

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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 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.

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