FDA 510(k)

MIS精準斜角槌狹系統

K 號：K211628 · 2022-01-31

決定日期2022-01-31

產品代碼HWC

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器材摘要

MIS Precision Chevron Bunion System is the device name listed in this FDA 510(k) record. The listed applicant is Relja Innovations, LLC. It received FDA 510(k) clearance on 2022-01-31 under 510(k) number K211628. 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 MIS Precision Chevron Bunion System?

MIS Precision Chevron Bunion System is a medical device that received FDA 510(k) clearance on 2022-01-31. The listed applicant is Relja Innovations, LLC. The 510(k) number is K211628.

When did MIS Precision Chevron Bunion System receive FDA 510(k) clearance?

MIS Precision Chevron Bunion System received FDA 510(k) clearance on 2022-01-31, under 510(k) number K211628.

Who is the listed applicant for MIS Precision Chevron Bunion System?

FDA 510(k) 記錄將 Relja Innovations, LLC 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for MIS Precision Chevron Bunion System?

The FDA product code for MIS Precision Chevron Bunion System is HWC. This falls under the Cardiovascular category.

其他以 Relja Innovations, 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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