FDA 510(k)

骨內融合設備系統

K 號：K231649 · 2023-09-29

決定日期2023-09-29

產品代碼HWC

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決定相當於

器材摘要

Intraosseous Fusion Device System is the device name listed in this FDA 510(k) record. The listed applicant is Auxano Medical, LLC. It received FDA 510(k) clearance on 2023-09-29 under 510(k) number K231649. 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 Intraosseous Fusion Device System?

Intraosseous Fusion Device System is a medical device that received FDA 510(k) clearance on 2023-09-29. The listed applicant is Auxano Medical, LLC. The 510(k) number is K231649.

When did Intraosseous Fusion Device System receive FDA 510(k) clearance?

Intraosseous Fusion Device System received FDA 510(k) clearance on 2023-09-29, under 510(k) number K231649.

Who is the listed applicant for Intraosseous Fusion Device System?

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

What is the FDA product code for Intraosseous Fusion Device System?

The FDA product code for Intraosseous Fusion Device System is HWC. This falls under the Cardiovascular category.

其他以 Auxano Medical, LLC 為申請人之記錄

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K251791Auxano® 極板固定系統

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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