FDA 510(k)

CONDUIT™ 零-P™ 維護隔離系統

K 號：K252982 · 2026-06-18

決定日期2026-06-18

產品代碼OVE

諮詢委員會或

決定相當於

器材摘要

CONDUIT™ ZERO-P™ VA Secured Spacer System is the device name listed in this FDA 510(k) record. The listed applicant is Avalign Technologies, Inc.. It received FDA 510(k) clearance on 2026-06-18 under 510(k) number K252982. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CONDUIT™ ZERO-P™ VA Secured Spacer System?

CONDUIT™ ZERO-P™ VA Secured Spacer System is a medical device that received FDA 510(k) clearance on 2026-06-18. The listed applicant is Avalign Technologies, Inc.. The 510(k) number is K252982.

When did CONDUIT™ ZERO-P™ VA Secured Spacer System receive FDA 510(k) clearance?

CONDUIT™ ZERO-P™ VA Secured Spacer System received FDA 510(k) clearance on 2026-06-18, under 510(k) number K252982.

Who is the listed applicant for CONDUIT™ ZERO-P™ VA Secured Spacer System?

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

What is the FDA product code for CONDUIT™ ZERO-P™ VA Secured Spacer System?

The FDA product code for CONDUIT™ ZERO-P™ VA Secured Spacer System is OVE.

其他以 Avalign Technologies, Inc. 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：OVE）

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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