FDA 510(k)

XT3 系統；XT3 系統，迷你型；XT3 系統，40mm；XT3 系統，迷你型，40mm

K 號：K260073 · 2026-02-10

決定日期2026-02-10

產品代碼JDW

諮詢委員會或

決定相當於

器材摘要

XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm is the device name listed in this FDA 510(k) record. The listed applicant is Biodynamik, Inc.. It received FDA 510(k) clearance on 2026-02-10 under 510(k) number K260073. The device is classified under product code JDW. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm?

XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm is a medical device that received FDA 510(k) clearance on 2026-02-10. The listed applicant is Biodynamik, Inc.. The 510(k) number is K260073.

When did XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm receive FDA 510(k) clearance?

XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm received FDA 510(k) clearance on 2026-02-10, under 510(k) number K260073.

Who is the listed applicant for XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm?

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

What is the FDA product code for XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm?

The FDA product code for XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm is JDW.

其他以 Biodynamik, Inc. 為申請人之記錄

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K241357XT3 系統

相關器械（代碼：JDW）

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。

K250316中樞骨內髓骨折固定（IFF）系統Meduloc, LLC K241357XT3 系統Biodynamik, Inc.K223112MAVERICK迷你外固定系統Smith & Nephew, Inc.K213874MAVERICK 外固定系統Smith & Nephew, Inc.K211508史坦曼針及克irschner 銅絲Stryker GmbH K210784延長型HA半針Smith & Nephew, Inc.

官方來源

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