FDA 510(k)

膝+

K 號：K253805 · 2026-04-24

決定日期2026-04-24

產品代碼SBF

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

Knee+ is the device name listed in this FDA 510(k) record. The listed applicant is Pixee Medical S.A.S.. It received FDA 510(k) clearance on 2026-04-24 under 510(k) number K253805. The device is classified under product code SBF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Knee+?

Knee+ is a medical device that received FDA 510(k) clearance on 2026-04-24. The listed applicant is Pixee Medical S.A.S.. The 510(k) number is K253805.

When did Knee+ receive FDA 510(k) clearance?

Knee+ received FDA 510(k) clearance on 2026-04-24, under 510(k) number K253805.

Who is the listed applicant for Knee+?

The FDA 510(k) record lists Pixee Medical S.A.S. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Knee+?

The FDA product code for Knee+ is SBF.

相關器械（代碼：SBF）

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。

K261854xvision脊椎系統Augmedics, Ltd.K252847NextAR 髋關節平台Medacta International S.A.K251639xvision脊椎系統Augmedics, Ltd.K252054脊椎AR SNAP（同步AR脊椎）Surgical Theater, Inc.K252530OptiVu™ 肩部Mr Surgical Solutions, LLC K251737NextAR™ 肩部平台Medacta International S.A.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。