FDA 510(k)

Pisces™-SA 独立式 ALIF 間體系統

K 號：K223413 · 2023-02-10

決定日期2023-02-10

產品代碼OVD

諮詢委員會或

決定相當於

器材摘要

Pisces™-SA STANDALONE ALIF Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is Osseus Fusion Systems. It received FDA 510(k) clearance on 2023-02-10 under 510(k) number K223413. 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 Pisces™-SA STANDALONE ALIF Interbody System?

Pisces™-SA STANDALONE ALIF Interbody System is a medical device that received FDA 510(k) clearance on 2023-02-10. The listed applicant is Osseus Fusion Systems. The 510(k) number is K223413.

When did Pisces™-SA STANDALONE ALIF Interbody System receive FDA 510(k) clearance?

Pisces™-SA STANDALONE ALIF Interbody System received FDA 510(k) clearance on 2023-02-10, under 510(k) number K223413.

Who is the listed applicant for Pisces™-SA STANDALONE ALIF Interbody System?

The FDA 510(k) record lists Osseus Fusion Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pisces™-SA STANDALONE ALIF Interbody System?

The FDA product code for Pisces™-SA STANDALONE ALIF Interbody System is OVD.

其他以 Osseus Fusion Systems 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：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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