FDA 510(k)

CoCr 頭部

K 號：K211047 · 2023-01-10

決定日期2023-01-10

產品代碼LPH

諮詢委員會或

決定相當於

器材摘要

CoCr Head is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer GmbH. It received FDA 510(k) clearance on 2023-01-10 under 510(k) number K211047. 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 CoCr Head?

CoCr Head is a medical device that received FDA 510(k) clearance on 2023-01-10. The listed applicant is Zimmer GmbH. The 510(k) number is K211047.

When did CoCr Head receive FDA 510(k) clearance?

CoCr Head received FDA 510(k) clearance on 2023-01-10, under 510(k) number K211047.

Who is the listed applicant for CoCr Head?

The FDA 510(k) record lists Zimmer GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CoCr Head?

The FDA product code for CoCr Head is LPH.

其他以 Zimmer GmbH 為申請人之記錄

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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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