FDA 510(k)

COGNiTiON™ 鋸釘系統

K 號：K240212 · 2024-02-23

決定日期2024-02-23

產品代碼JDR

諮詢委員會或

決定相當於

器材摘要

COGNiTiON™ Staple System is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Solutions UK , Ltd.. It received FDA 510(k) clearance on 2024-02-23 under 510(k) number K240212. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the COGNiTiON™ Staple System?

COGNiTiON™ Staple System is a medical device that received FDA 510(k) clearance on 2024-02-23. The listed applicant is Ortho Solutions UK , Ltd.. The 510(k) number is K240212.

When did COGNiTiON™ Staple System receive FDA 510(k) clearance?

COGNiTiON™ Staple System received FDA 510(k) clearance on 2024-02-23, under 510(k) number K240212.

Who is the listed applicant for COGNiTiON™ Staple System?

The FDA 510(k) record lists Ortho Solutions UK , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COGNiTiON™ Staple System?

The FDA product code for COGNiTiON™ Staple System is JDR.

其他以 Ortho Solutions UK , Ltd. 為申請人之記錄

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