FDA 510(k)

Zimed 遠端內側胫骨板及螺釘系統

K 號：K230507 · 2024-01-04

決定日期2024-01-04

產品代碼HWC

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器材摘要

Zimed Distal Medial Tibial Plate and Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Zimed Medikal. It received FDA 510(k) clearance on 2024-01-04 under 510(k) number K230507. 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 Zimed Distal Medial Tibial Plate and Screw System?

Zimed Distal Medial Tibial Plate and Screw System is a medical device that received FDA 510(k) clearance on 2024-01-04. The listed applicant is Zimed Medikal. The 510(k) number is K230507.

When did Zimed Distal Medial Tibial Plate and Screw System receive FDA 510(k) clearance?

Zimed Distal Medial Tibial Plate and Screw System received FDA 510(k) clearance on 2024-01-04, under 510(k) number K230507.

Who is the listed applicant for Zimed Distal Medial Tibial Plate and Screw System?

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

What is the FDA product code for Zimed Distal Medial Tibial Plate and Screw System?

The FDA product code for Zimed Distal Medial Tibial Plate and Screw System is HWC. This falls under the Cardiovascular category.

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器材摘要

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相關器械（代碼：HWC）

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