FDA 510(k)

PINNACLE™ 縫合式骨盂內襯

K 號：K240639 · 2024-04-04

決定日期2024-04-04

產品代碼KWZ

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決定相當於

器材摘要

PINNACLETM Constrained Acetabular Liners is the device name listed in this FDA 510(k) record. The listed applicant is Depuy Ireland UC. It received FDA 510(k) clearance on 2024-04-04 under 510(k) number K240639. The device is classified under product code KWZ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the PINNACLETM Constrained Acetabular Liners?

PINNACLETM Constrained Acetabular Liners is a medical device that received FDA 510(k) clearance on 2024-04-04. The listed applicant is Depuy Ireland UC. The 510(k) number is K240639.

When did PINNACLETM Constrained Acetabular Liners receive FDA 510(k) clearance?

PINNACLETM Constrained Acetabular Liners received FDA 510(k) clearance on 2024-04-04, under 510(k) number K240639.

Who is the listed applicant for PINNACLETM Constrained Acetabular Liners?

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

What is the FDA product code for PINNACLETM Constrained Acetabular Liners?

The FDA product code for PINNACLETM Constrained Acetabular Liners is KWZ.

其他以 Depuy Ireland UC 為申請人之記錄

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相關器械（代碼：KWZ）

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。

K241461Mpact 縮限內層材Medacta International S.A.K162641史密斯與內夫公司 R3™ 縫合內襯Smith & Nephew, Inc.K163497EXPRT™ 髋關節系統 - EXPRT™ 髋關節遠端柄，EXPRT™ 髋關節標準偏心近端體植入物，EXPRT™ 髋關節側偏心近端體植入物，EXPRT™ 髋關節抓握螺栓Encore Medical L.P.K161610EXPRT 髋關修復系統Encore Medical L.P.

官方來源

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