FDA 510(k)

DYNEX® 外固定系統

K 號：K260900 · 2026-04-17

決定日期2026-04-17

產品代碼KTT

諮詢委員會或

決定相當於

器材摘要

DYNEX® External Fixation Systems is the device name listed in this FDA 510(k) record. The listed applicant is Vilex, LLC. It received FDA 510(k) clearance on 2026-04-17 under 510(k) number K260900. 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 DYNEX® External Fixation Systems?

DYNEX® External Fixation Systems is a medical device that received FDA 510(k) clearance on 2026-04-17. The listed applicant is Vilex, LLC. The 510(k) number is K260900.

When did DYNEX® External Fixation Systems receive FDA 510(k) clearance?

DYNEX® External Fixation Systems received FDA 510(k) clearance on 2026-04-17, under 510(k) number K260900.

Who is the listed applicant for DYNEX® External Fixation Systems?

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

What is the FDA product code for DYNEX® External Fixation Systems?

The FDA product code for DYNEX® External Fixation Systems is KTT.

其他以 Vilex, LLC 為申請人之記錄

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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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, LLC K260112QuikFix 外固定器：膝蓋跨包Stabiliz Orthopaedics, Inc.K253291優越系統Blue Ocean Global K253202霍夫曼LRF系統Stryker GmbH K253613猴環外環固定系統Paragon 28, Inc.K252555美杜莎骨科 Boa 外固定系統Medusa Orthopedics, LLC

官方來源

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