FDA 510(k)

Nexis® 压縮螺釘

K 號：K223468 · 2023-08-30

決定日期2023-08-30

產品代碼HWC

諮詢委員會或

決定相當於

器材摘要

Nexis® compressive screws is the device name listed in this FDA 510(k) record. The listed applicant is Novastep. It received FDA 510(k) clearance on 2023-08-30 under 510(k) number K223468. 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 Nexis® compressive screws?

Nexis® compressive screws is a medical device that received FDA 510(k) clearance on 2023-08-30. The listed applicant is Novastep. The 510(k) number is K223468.

When did Nexis® compressive screws receive FDA 510(k) clearance?

Nexis® compressive screws received FDA 510(k) clearance on 2023-08-30, under 510(k) number K223468.

Who is the listed applicant for Nexis® compressive screws?

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

What is the FDA product code for Nexis® compressive screws?

The FDA product code for Nexis® compressive screws is HWC. This falls under the Cardiovascular category.

其他以 Novastep 為申請人之記錄

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官方來源

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