FDA 510(k)

G7® 修訂型骨盆杯系統

K 號：K252623 · 2026-02-04

決定日期2026-02-04

產品代碼LPH

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器材摘要

G7® Revision Acetabular System is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer, Inc.. It received FDA 510(k) clearance on 2026-02-04 under 510(k) number K252623. 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 G7® Revision Acetabular System?

G7® Revision Acetabular System is a medical device that received FDA 510(k) clearance on 2026-02-04. The listed applicant is Zimmer, Inc.. The 510(k) number is K252623.

When did G7® Revision Acetabular System receive FDA 510(k) clearance?

G7® Revision Acetabular System received FDA 510(k) clearance on 2026-02-04, under 510(k) number K252623.

Who is the listed applicant for G7® Revision Acetabular System?

FDA 510(k) 記錄將 Zimmer, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for G7® Revision Acetabular System?

The FDA product code for G7® Revision Acetabular System is LPH.

其他以 Zimmer, Inc. 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。

K262955OsseoFit無柄肩部系統 K260831Z1 髋關節系統 K261683Augment 偏心儀器系統 K251840齊默® 佩森娜® 適合個人化膝關節系統 K260182Avenir® Müller 植入物；Avenir Complete™ 髋關節系統 K253592Zimmer Biomet 反向肩蓋假體（Alliance 肱骨承重環，Identity 肱骨托盤，全面性反向肱骨托盤，全面性反向 32mm 髋球和適配器）

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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.

官方來源

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