FDA 510(k)

Ventana™ A 前腰椎間體系統

K 號：K253559 · 2026-02-25

決定日期2026-02-25

產品代碼OVD

諮詢委員會或

決定相當於

器材摘要

Ventana™ A Anterior Lumbar Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is Spinal Elements, Inc.. It received FDA 510(k) clearance on 2026-02-25 under 510(k) number K253559. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Ventana™ A Anterior Lumbar Interbody System?

Ventana™ A Anterior Lumbar Interbody System is a medical device that received FDA 510(k) clearance on 2026-02-25. The listed applicant is Spinal Elements, Inc.. The 510(k) number is K253559.

When did Ventana™ A Anterior Lumbar Interbody System receive FDA 510(k) clearance?

Ventana™ A Anterior Lumbar Interbody System received FDA 510(k) clearance on 2026-02-25, under 510(k) number K253559.

Who is the listed applicant for Ventana™ A Anterior Lumbar Interbody System?

The FDA 510(k) record lists Spinal Elements, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ventana™ A Anterior Lumbar Interbody System?

The FDA product code for Ventana™ A Anterior Lumbar Interbody System is OVD.

其他以 Spinal Elements, Inc. 為申請人之記錄

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相關器械（代碼：OVD）

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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