FDA 510(k)

ConfoMIS iTotal 門鎖式交叉韌帶保留（CR）膝蓋置換系統（iTotal CR KRS）

K 號：K161366 · 2016-06-14

決定日期2016-06-14

產品代碼JWH

諮詢委員會或

決定相當於

器材摘要

ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS) is the device name listed in this FDA 510(k) record. The listed applicant is Conformis, Inc.. It received FDA 510(k) clearance on 2016-06-14 under 510(k) number K161366. 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 ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS)?

ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS) is a medical device that received FDA 510(k) clearance on 2016-06-14. The listed applicant is Conformis, Inc.. The 510(k) number is K161366.

When did ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS) receive FDA 510(k) clearance?

ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS) received FDA 510(k) clearance on 2016-06-14, under 510(k) number K161366.

Who is the listed applicant for ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS)?

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 ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS)?

The FDA product code for ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS) 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 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：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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