FDA 510(k)

HipXpert 3D顯示與固定應用程序

K 號：K200384 · 2021-01-28

決定日期2021-01-28

產品代碼OSF

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

HipXpert 3D Display and Anchoring Application is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Planning Associates, Inc.. It received FDA 510(k) clearance on 2021-01-28 under 510(k) number K200384. The device is classified under product code OSF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the HipXpert 3D Display and Anchoring Application?

HipXpert 3D Display and Anchoring Application is a medical device that received FDA 510(k) clearance on 2021-01-28. The listed applicant is Surgical Planning Associates, Inc.. The 510(k) number is K200384.

When did HipXpert 3D Display and Anchoring Application receive FDA 510(k) clearance?

HipXpert 3D Display and Anchoring Application received FDA 510(k) clearance on 2021-01-28, under 510(k) number K200384.

Who is the listed applicant for HipXpert 3D Display and Anchoring Application?

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

What is the FDA product code for HipXpert 3D Display and Anchoring Application?

The FDA product code for HipXpert 3D Display and Anchoring Application is OSF.

其他以 Surgical Planning Associates, 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。

K233315HipXpert及HipInsight系統

相關器械（代碼：OSF）

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。

K233315HipXpert及HipInsight系統Surgical Planning Associates, Inc.

官方來源

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