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FDA 510(k)

SMART骨切系統

K 號：K260090 · 2026-04-10

申請人Actis Medical Pty., Ltd.
決定日期2026-04-10
產品代碼HRS
諮詢委員會或
決定相當於

器材摘要

SMART Osteotomy System is the device name listed in this FDA 510(k) record. The listed applicant is Actis Medical Pty., Ltd.. It received FDA 510(k) clearance on 2026-04-10 under 510(k) number K260090. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SMART Osteotomy System?

SMART Osteotomy System is a medical device that received FDA 510(k) clearance on 2026-04-10. The listed applicant is Actis Medical Pty., Ltd.. The 510(k) number is K260090.

When did SMART Osteotomy System receive FDA 510(k) clearance?

SMART Osteotomy System received FDA 510(k) clearance on 2026-04-10, under 510(k) number K260090.

Who is the listed applicant for SMART Osteotomy System?

The FDA 510(k) record lists Actis Medical Pty., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SMART Osteotomy System?

The FDA product code for SMART Osteotomy System is HRS.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

相關器械（代碼：HRS）

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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官方來源

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