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FDA 510(k)

Sequel 外固定設備

K 號：K202833 · 2021-01-19

申請人Sequel Medical, Inc.
決定日期2021-01-19
產品代碼KTT
諮詢委員會或
決定相當於

器材摘要

Sequel External Fixation Device is the device name listed in this FDA 510(k) record. The listed applicant is Sequel Medical, Inc.. It received FDA 510(k) clearance on 2021-01-19 under 510(k) number K202833. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Sequel External Fixation Device?

Sequel External Fixation Device is a medical device that received FDA 510(k) clearance on 2021-01-19. The listed applicant is Sequel Medical, Inc.. The 510(k) number is K202833.

When did Sequel External Fixation Device receive FDA 510(k) clearance?

Sequel External Fixation Device received FDA 510(k) clearance on 2021-01-19, under 510(k) number K202833.

Who is the listed applicant for Sequel External Fixation Device?

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

What is the FDA product code for Sequel External Fixation Device?

The FDA product code for Sequel External Fixation Device is KTT.

相關臨床試驗

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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：KTT）

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。

K254087MAXFRAME AUTOSTRUT™ 內建藍牙多軸校正系統Synthes (USA) Products, LLCK260900DYNEX® 外固定系統Vilex, LLCK260112QuikFix 外固定器：膝蓋跨包Stabiliz Orthopaedics, Inc.K253291優越系統Blue Ocean GlobalK253613猴環外環固定系統Paragon 28, Inc.K253202霍夫曼LRF系統Stryker GmbH

官方來源

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