FDA 510(k)

SAGICO脊椎系統

K 號：K223143 · 2023-06-26

決定日期2023-06-26

產品代碼OVE

諮詢委員會或

決定相當於

器材摘要

SAGICO Spinal System is the device name listed in this FDA 510(k) record. The listed applicant is Sagico VA USA, LLC. It received FDA 510(k) clearance on 2023-06-26 under 510(k) number K223143. 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 SAGICO Spinal System?

SAGICO Spinal System is a medical device that received FDA 510(k) clearance on 2023-06-26. The listed applicant is Sagico VA USA, LLC. The 510(k) number is K223143.

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

SAGICO Spinal System received FDA 510(k) clearance on 2023-06-26, under 510(k) number K223143.

Who is the listed applicant for SAGICO Spinal System?

The FDA 510(k) record lists Sagico VA USA, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SAGICO Spinal System?

The FDA product code for SAGICO Spinal System is OVE.

其他以 Sagico VA USA, LLC 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。

K232561Ripley脊椎螺釘系統 by SAGICO K221138提圖斯钛制頸椎設備，由SAGICO生產

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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