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FDA 510(k)

Duet™脊椎固定系統

K 號：K253169 · 2026-02-23

申請人Box Spine, LLC
決定日期2026-02-23
產品代碼NKB
諮詢委員會或
決定相當於

器材摘要

Duet™ Spinal Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Box Spine, LLC. It received FDA 510(k) clearance on 2026-02-23 under 510(k) number K253169. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Duet™ Spinal Fixation System?

Duet™ Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2026-02-23. The listed applicant is Box Spine, LLC. The 510(k) number is K253169.

When did Duet™ Spinal Fixation System receive FDA 510(k) clearance?

Duet™ Spinal Fixation System received FDA 510(k) clearance on 2026-02-23, under 510(k) number K253169.

Who is the listed applicant for Duet™ Spinal Fixation System?

The FDA 510(k) record lists Box Spine, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Duet™ Spinal Fixation System?

The FDA product code for Duet™ Spinal Fixation System is NKB.

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：NKB）

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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