FDA 510(k)

提圖斯钛制頸椎設備，由SAGICO生產

K 號：K221138 · 2023-08-04

決定日期2023-08-04

產品代碼OVE

諮詢委員會或

決定相當於

器材摘要

Titus Titanium Cervical by SAGICO 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 2023-08-04 under 510(k) number K221138. 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 Titus Titanium Cervical by SAGICO?

Titus Titanium Cervical by SAGICO is a medical device that received FDA 510(k) clearance on 2023-08-04. The listed applicant is Sagico VA USA, LLC. The 510(k) number is K221138.

When did Titus Titanium Cervical by SAGICO receive FDA 510(k) clearance?

Titus Titanium Cervical by SAGICO received FDA 510(k) clearance on 2023-08-04, under 510(k) number K221138.

Who is the listed applicant for Titus Titanium Cervical by SAGICO?

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 Titus Titanium Cervical by SAGICO?

The FDA product code for Titus Titanium Cervical by SAGICO 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 K223143SAGICO脊椎系統

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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