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FDA 510(k)

奧米尼亞醫療創傷螺釘

K 號：K192096 · 2020-02-27

申請人Omnia Medical, LLC
決定日期2020-02-27
產品代碼HWC
諮詢委員會或
決定相當於

器材摘要

Omnia Medical Trauma Screws is the device name listed in this FDA 510(k) record. The listed applicant is Omnia Medical, LLC. It received FDA 510(k) clearance on 2020-02-27 under 510(k) number K192096. 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 Omnia Medical Trauma Screws?

Omnia Medical Trauma Screws is a medical device that received FDA 510(k) clearance on 2020-02-27. The listed applicant is Omnia Medical, LLC. The 510(k) number is K192096.

When did Omnia Medical Trauma Screws receive FDA 510(k) clearance?

Omnia Medical Trauma Screws received FDA 510(k) clearance on 2020-02-27, under 510(k) number K192096.

Who is the listed applicant for Omnia Medical Trauma Screws?

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

What is the FDA product code for Omnia Medical Trauma Screws?

The FDA product code for Omnia Medical Trauma Screws is HWC. This falls under the Cardiovascular category.

相關臨床試驗

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其他以 Omnia Medical, LLC 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。

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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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