FDA 510(k)

快速開始骨科固定釘及反向螺紋釘

K 號：K231819 · 2023-09-05

決定日期2023-09-05

產品代碼HWC

諮詢委員會或

決定相當於

器材摘要

Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw 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 2023-09-05 under 510(k) number K231819. 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 Orthopaedic Fixation Screw and Reverse Thread Screw?

Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw is a medical device that received FDA 510(k) clearance on 2023-09-05. The listed applicant is Innovate Orthopaedics Limited. The 510(k) number is K231819.

When did Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw receive FDA 510(k) clearance?

Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw received FDA 510(k) clearance on 2023-09-05, under 510(k) number K231819.

Who is the listed applicant for Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw?

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 Orthopaedic Fixation Screw and Reverse Thread Screw?

The FDA product code for Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw 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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K212547快速開始螺絲

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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