FDA 510(k)

HKT解剖固定創傷系統

K 號：K254249 · 2026-02-27

決定日期2026-02-27

產品代碼HRS

諮詢委員會或

決定相當於

器材摘要

HKT Anatomical Locking Trauma System is the device name listed in this FDA 510(k) record. The listed applicant is Hankil Tech Medical Co., Ltd.. It received FDA 510(k) clearance on 2026-02-27 under 510(k) number K254249. 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 HKT Anatomical Locking Trauma System?

HKT Anatomical Locking Trauma System is a medical device that received FDA 510(k) clearance on 2026-02-27. The listed applicant is Hankil Tech Medical Co., Ltd.. The 510(k) number is K254249.

When did HKT Anatomical Locking Trauma System receive FDA 510(k) clearance?

HKT Anatomical Locking Trauma System received FDA 510(k) clearance on 2026-02-27, under 510(k) number K254249.

Who is the listed applicant for HKT Anatomical Locking Trauma System?

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

What is the FDA product code for HKT Anatomical Locking Trauma System?

The FDA product code for HKT Anatomical Locking Trauma System is HRS.

其他以 Hankil Tech Medical Co., Ltd. 為申請人之記錄

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K231213HKT解剖固定創傷系統

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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