FDA 510(k)

Actera™ 髋關節系統

K 號：K221104 · 2022-08-04

決定日期2022-08-04

產品代碼MEH

諮詢委員會或

決定相當於

器材摘要

Actera™ hip system is the device name listed in this FDA 510(k) record. The listed applicant is Conformis, Inc.. It received FDA 510(k) clearance on 2022-08-04 under 510(k) number K221104. The device is classified under product code MEH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Actera™ hip system?

Actera™ hip system is a medical device that received FDA 510(k) clearance on 2022-08-04. The listed applicant is Conformis, Inc.. The 510(k) number is K221104.

When did Actera™ hip system receive FDA 510(k) clearance?

Actera™ hip system received FDA 510(k) clearance on 2022-08-04, under 510(k) number K221104.

Who is the listed applicant for Actera™ hip system?

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

What is the FDA product code for Actera™ hip system?

The FDA product code for Actera™ hip system is MEH.

其他以 Conformis, 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。

K232426身份印記多孔交叉韌帶保留（CR）膝蓋置換系統（KRS）搭配交叉韌帶犧牲（CS）插片 K223316身份印記多孔全膝關節置換系統，身份印記多孔交叉維持全膝關節置換系統 K230846iTotal Identity 適合膝關節置換系統；Identity Imprint 適合膝關節置換系統 K231233Identity™ 印記™ CR KRS 和 Identity™ 印記™ PS KRS K231178ACTERA™ 髋關節系統 K230844身份印記內側副鍵節保留（CR）膝蓋置換系統（KRS）搭配內側副鍵節犧牲（CS）插件

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相關器械（代碼：MEH）

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。

K261576象納髋關節置入體Corin, Ltd.K250375Allure骨盆柄和骨髓內插釘Waldemar Link GmbH & Co. KG K251166Mfinity 髋關系統Medacta International S.A.K251052Trivicta® 髋關節柄Ortho Development Corp.K242315解決模組化修復股骨柄United Orthopedic Corporation K243839Alteon® HA Femoral StemsExactech, Inc.

官方來源

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