FDA 510(k)

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

K 號：K230844 · 2023-04-27

決定日期2023-04-27

產品代碼JWH

諮詢委員會或

決定相當於

器材摘要

Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Insert is the device name listed in this FDA 510(k) record. The listed applicant is Conformis, Inc.. It received FDA 510(k) clearance on 2023-04-27 under 510(k) number K230844. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Insert?

Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Insert is a medical device that received FDA 510(k) clearance on 2023-04-27. The listed applicant is Conformis, Inc.. The 510(k) number is K230844.

When did Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Insert receive FDA 510(k) clearance?

Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Insert received FDA 510(k) clearance on 2023-04-27, under 510(k) number K230844.

Who is the listed applicant for Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Insert?

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 Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Insert?

The FDA product code for Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Insert is JWH.

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 K221104Actera™ 髋關節系統

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相關器械（代碼：JWH）

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。

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官方來源

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