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FDA 510(k)

乙烯氧化物消毒供應商更換對MPO髋關節的規範

K 號：K240046 · 2024-04-18

申請人Microport Orthopedics
決定日期2024-04-18
產品代碼LPH
諮詢委員會或
決定相當於

器材摘要

Ethylene Oxide Sterilization Supplier Change for MPO Hips is the device name listed in this FDA 510(k) record. The listed applicant is Microport Orthopedics. It received FDA 510(k) clearance on 2024-04-18 under 510(k) number K240046. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Ethylene Oxide Sterilization Supplier Change for MPO Hips?

Ethylene Oxide Sterilization Supplier Change for MPO Hips is a medical device that received FDA 510(k) clearance on 2024-04-18. The listed applicant is Microport Orthopedics. The 510(k) number is K240046.

When did Ethylene Oxide Sterilization Supplier Change for MPO Hips receive FDA 510(k) clearance?

Ethylene Oxide Sterilization Supplier Change for MPO Hips received FDA 510(k) clearance on 2024-04-18, under 510(k) number K240046.

Who is the listed applicant for Ethylene Oxide Sterilization Supplier Change for MPO Hips?

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

What is the FDA product code for Ethylene Oxide Sterilization Supplier Change for MPO Hips?

The FDA product code for Ethylene Oxide Sterilization Supplier Change for MPO Hips is LPH.

相關臨床試驗

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：LPH）

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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