FDA 510(k)

NextAR 髋關節平台

K 號：K252847 · 2026-01-09

決定日期2026-01-09

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

NextAR Hip Platform is the device name listed in this FDA 510(k) record. The listed applicant is Medacta International S.A.. It received FDA 510(k) clearance on 2026-01-09 under 510(k) number K252847. 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 NextAR Hip Platform?

NextAR Hip Platform is a medical device that received FDA 510(k) clearance on 2026-01-09. The listed applicant is Medacta International S.A.. The 510(k) number is K252847.

When did NextAR Hip Platform receive FDA 510(k) clearance?

NextAR Hip Platform received FDA 510(k) clearance on 2026-01-09, under 510(k) number K252847.

Who is the listed applicant for NextAR Hip Platform?

FDA 510(k) 記錄將 Medacta International S.A. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for NextAR Hip Platform?

The FDA product code for NextAR Hip Platform is SBF.

其他以 Medacta International S.A. 為申請人之記錄

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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.K253805膝+Pixee Medical S.A.S.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

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