FDA 510(k)

ARTFX 骨折骨板和螺釘系統

K 號：K242939 · 2024-12-23

決定日期2024-12-23

產品代碼HRS

諮詢委員會或

決定相當於

器材摘要

ARTFX Trauma Bone Plate and Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Artfx Medical. It received FDA 510(k) clearance on 2024-12-23 under 510(k) number K242939. 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 ARTFX Trauma Bone Plate and Screw System?

ARTFX Trauma Bone Plate and Screw System is a medical device that received FDA 510(k) clearance on 2024-12-23. The listed applicant is Artfx Medical. The 510(k) number is K242939.

When did ARTFX Trauma Bone Plate and Screw System receive FDA 510(k) clearance?

ARTFX Trauma Bone Plate and Screw System received FDA 510(k) clearance on 2024-12-23, under 510(k) number K242939.

Who is the listed applicant for ARTFX Trauma Bone Plate and Screw System?

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

What is the FDA product code for ARTFX Trauma Bone Plate and Screw System?

The FDA product code for ARTFX Trauma Bone Plate and Screw System is HRS.

其他以 Artfx Medical 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。

K240889ARTFX 腰椎 PEEK 盒 K240893ARTFX 医療頸椎 PEEK 盒

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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官方來源

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