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FDA 510(k)

COGNiTiON™ Staple System

K-Number: K240212 · 2024-02-23

Decision Date2024-02-23
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

What is the COGNiTiON™ Staple System?

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

When was COGNiTiON™ Staple System approved by the FDA?

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

What company makes COGNiTiON™ Staple System?

COGNiTiON™ Staple System is manufactured by Ortho Solutions UK , Ltd..

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

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

Related Clinical Trials

Other Devices by Ortho Solutions UK , Ltd.

Related Devices (Code: JDR)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.