FDA 510(k)

維特里斯椎間體融合設備

K 號：K243386 · 2025-04-22

決定日期2025-04-22

產品代碼OVD

諮詢委員會或

決定相當於

器材摘要

Ventris Intervertebral Body Fusion Device is the device name listed in this FDA 510(k) record. The listed applicant is Acuity Surgical Devices, LLC. It received FDA 510(k) clearance on 2025-04-22 under 510(k) number K243386. 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 Ventris Intervertebral Body Fusion Device?

Ventris Intervertebral Body Fusion Device is a medical device that received FDA 510(k) clearance on 2025-04-22. The listed applicant is Acuity Surgical Devices, LLC. The 510(k) number is K243386.

When did Ventris Intervertebral Body Fusion Device receive FDA 510(k) clearance?

Ventris Intervertebral Body Fusion Device received FDA 510(k) clearance on 2025-04-22, under 510(k) number K243386.

Who is the listed applicant for Ventris Intervertebral Body Fusion Device?

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

What is the FDA product code for Ventris Intervertebral Body Fusion Device?

The FDA product code for Ventris Intervertebral Body Fusion Device is OVD.

其他以 Acuity Surgical Devices, LLC 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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