FDA 510(k)

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K 號：K212547 · 2021-12-30

決定日期2021-12-30

產品代碼HWC

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器材摘要

Quick-Start Screws is the device name listed in this FDA 510(k) record. The listed applicant is Innovate Orthopaedics Limited. It received FDA 510(k) clearance on 2021-12-30 under 510(k) number K212547. 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 Quick-Start Screws?

Quick-Start Screws is a medical device that received FDA 510(k) clearance on 2021-12-30. The listed applicant is Innovate Orthopaedics Limited. The 510(k) number is K212547.

When did Quick-Start Screws receive FDA 510(k) clearance?

Quick-Start Screws received FDA 510(k) clearance on 2021-12-30, under 510(k) number K212547.

Who is the listed applicant for Quick-Start Screws?

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

What is the FDA product code for Quick-Start Screws?

The FDA product code for Quick-Start Screws is HWC. This falls under the Cardiovascular category.

其他以 Innovate Orthopaedics Limited 為申請人之記錄

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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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