FDA 510(k)

Medline UNITE® MIS足部重建螺釘系統

K 號：K241359 · 2024-08-02

決定日期2024-08-02

產品代碼HWC

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器材摘要

Medline UNITE® MIS Foot Recon Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Medline Industries, LP. It received FDA 510(k) clearance on 2024-08-02 under 510(k) number K241359. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常見問題

What is the Medline UNITE® MIS Foot Recon Screw System?

Medline UNITE® MIS Foot Recon Screw System is a medical device that received FDA 510(k) clearance on 2024-08-02. The listed applicant is Medline Industries, LP. The 510(k) number is K241359.

When did Medline UNITE® MIS Foot Recon Screw System receive FDA 510(k) clearance?

Medline UNITE® MIS Foot Recon Screw System received FDA 510(k) clearance on 2024-08-02, under 510(k) number K241359.

Who is the listed applicant for Medline UNITE® MIS Foot Recon Screw System?

FDA 510(k) 記錄中將 Medline Industries, LP 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Medline UNITE® MIS Foot Recon Screw System?

The FDA product code for Medline UNITE® MIS Foot Recon Screw System is HWC. This falls under the Cardiovascular category.

其他以 Medline Industries, LP 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。

K253526NAMIC 扩張器及套管 K254287Medline可重用血壓袖帶 K253322Hudson RCI®嬰兒乾燥技術TM呼吸回路 (HUD99060 / 乾燥技術配78英寸嬰兒回路，HUD99060KIT / 乾燥技術配78英寸嬰兒回路套件，HUD99001KIT / 单臂嬰兒回路乾燥技術套件，HUD99009KIT / 乾燥技術配60英寸嬰兒回路套件，HUD99018KIT / 乾燥技術配44英寸嬰兒回路套件，HUD870NKIT / 乾燥技術嬰兒配件袋，HUD1631 / 嬰兒Y型接頭配轉動環)K251687康尼格貝爾環切夾 K253070Namic 放射臂帶，23 公分（DYNJRADBAND）；Namic 放射臂帶，26 公分（DYNJRADBANDL）K250345美林袋式分酒器

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相關器械（代碼：HWC）

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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