FDA 510(k)

自由後頸椎螺釘

K 號：K242674 · 2025-05-13

決定日期2025-05-13

產品代碼NKG

諮詢委員會或

決定相當於

器材摘要

Freedom Posterior Cervical Screws is the device name listed in this FDA 510(k) record. The listed applicant is Signature Orthopaedics Pty, Ltd.. It received FDA 510(k) clearance on 2025-05-13 under 510(k) number K242674. The device is classified under product code NKG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Freedom Posterior Cervical Screws?

Freedom Posterior Cervical Screws is a medical device that received FDA 510(k) clearance on 2025-05-13. The listed applicant is Signature Orthopaedics Pty, Ltd.. The 510(k) number is K242674.

When did Freedom Posterior Cervical Screws receive FDA 510(k) clearance?

Freedom Posterior Cervical Screws received FDA 510(k) clearance on 2025-05-13, under 510(k) number K242674.

Who is the listed applicant for Freedom Posterior Cervical Screws?

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

What is the FDA product code for Freedom Posterior Cervical Screws?

The FDA product code for Freedom Posterior Cervical Screws is NKG.

其他以 Signature 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。

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相關器械（代碼：NKG）

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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