FDA 510(k)

骨釘系統

K 號：K230867 · 2023-06-26

申請人University of Utah, Department of Orthopaedics

決定日期2023-06-26

產品代碼HWC

諮詢委員會或

決定相當於

器材摘要

Bone Bolt System is the device name listed in this FDA 510(k) record. The listed applicant is University of Utah, Department of Orthopaedics. It received FDA 510(k) clearance on 2023-06-26 under 510(k) number K230867. 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 Bone Bolt System?

Bone Bolt System is a medical device that received FDA 510(k) clearance on 2023-06-26. The listed applicant is University of Utah, Department of Orthopaedics. The 510(k) number is K230867.

When did Bone Bolt System receive FDA 510(k) clearance?

Bone Bolt System received FDA 510(k) clearance on 2023-06-26, under 510(k) number K230867.

Who is the listed applicant for Bone Bolt System?

The FDA 510(k) record lists University of Utah, Department of Orthopaedics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bone Bolt System?

The FDA product code for Bone Bolt System is HWC. This falls under the Cardiovascular category.

其他以 University of Utah, Department of Orthopaedics 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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