FDA 510(k)

維特洛克脊椎系統

K 號：K231134 · 2024-02-13

決定日期2024-02-13

產品代碼MQP

諮詢委員會或

決定相當於

器材摘要

VerteLoc Spinal System 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 2024-02-13 under 510(k) number K231134. The device is classified under product code MQP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the VerteLoc Spinal System?

VerteLoc Spinal System is a medical device that received FDA 510(k) clearance on 2024-02-13. The listed applicant is Signature Orthopaedics Pty, Ltd.. The 510(k) number is K231134.

When did VerteLoc Spinal System receive FDA 510(k) clearance?

VerteLoc Spinal System received FDA 510(k) clearance on 2024-02-13, under 510(k) number K231134.

Who is the listed applicant for VerteLoc Spinal System?

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 VerteLoc Spinal System?

The FDA product code for VerteLoc Spinal System is MQP.

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

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相關器械（代碼：MQP）

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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