FDA 510(k)

骨傷外用系統（BTES）螺釘範圍，NX釘

K 號：K230118 · 2023-02-16

決定日期2023-02-16

產品代碼HWC

諮詢委員會或

決定相當於

器材摘要

Bony Trauma Extremity System (BTES) Screw Range, NX Nail is the device name listed in this FDA 510(k) record. The listed applicant is Field Orthopaedics Pty, Ltd.. It received FDA 510(k) clearance on 2023-02-16 under 510(k) number K230118. 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 Bony Trauma Extremity System (BTES) Screw Range, NX Nail?

Bony Trauma Extremity System (BTES) Screw Range, NX Nail is a medical device that received FDA 510(k) clearance on 2023-02-16. The listed applicant is Field Orthopaedics Pty, Ltd.. The 510(k) number is K230118.

When did Bony Trauma Extremity System (BTES) Screw Range, NX Nail receive FDA 510(k) clearance?

Bony Trauma Extremity System (BTES) Screw Range, NX Nail received FDA 510(k) clearance on 2023-02-16, under 510(k) number K230118.

Who is the listed applicant for Bony Trauma Extremity System (BTES) Screw Range, NX Nail?

The FDA 510(k) record lists Field Orthopaedics Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bony Trauma Extremity System (BTES) Screw Range, NX Nail?

The FDA product code for Bony Trauma Extremity System (BTES) Screw Range, NX Nail is HWC. This falls under the Cardiovascular category.

其他以 Field Orthopaedics Pty, Ltd. 為申請人之記錄

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。

K200043骨科骨科骨傷外用系統（BTES）板範圍和板螺釘；骨科骨科骨傷外用系統（BTES）螺釘範圍 K180348骨科微釘系統

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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官方來源

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