FDA 510(k)

Corin最佳定位系統功能髋關節分析（OPS FHA）

K 號：K190834 · 2019-07-22

決定日期2019-07-22

產品代碼LZO

諮詢委員會或

決定相當於

器材摘要

Corin Optimized Position System Functional Hip Analysis (OPS FHA) is the device name listed in this FDA 510(k) record. The listed applicant is Corin USA. It received FDA 510(k) clearance on 2019-07-22 under 510(k) number K190834. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Corin Optimized Position System Functional Hip Analysis (OPS FHA)?

Corin Optimized Position System Functional Hip Analysis (OPS FHA) is a medical device that received FDA 510(k) clearance on 2019-07-22. The listed applicant is Corin USA. The 510(k) number is K190834.

When did Corin Optimized Position System Functional Hip Analysis (OPS FHA) receive FDA 510(k) clearance?

Corin Optimized Position System Functional Hip Analysis (OPS FHA) received FDA 510(k) clearance on 2019-07-22, under 510(k) number K190834.

Who is the listed applicant for Corin Optimized Position System Functional Hip Analysis (OPS FHA)?

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

What is the FDA product code for Corin Optimized Position System Functional Hip Analysis (OPS FHA)?

The FDA product code for Corin Optimized Position System Functional Hip Analysis (OPS FHA) is LZO.

其他以 Corin USA 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。

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相關器械（代碼：LZO）

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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