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FDA 510(k)

COGNiTiON™ Staple System

K-Number: K240212 · 2024-02-23

ApplicantOrtho Solutions UK , Ltd.
Decision Date2024-02-23
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

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.

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. 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.

Other records listing Ortho Solutions UK , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250622Succession™ AFN SystemK210658Volition Plating SystemK202764Ortho Solutions Plating SystemK163489OrthoSolutions 'System26' Bone Screws

Related Devices (Code: JDR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261121Megalodon Dynamic Compression SystemParagon 28, Inc.K250712Linkt Compression Staple SystemTrax SurgicalK243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LPK243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.K243658TMC Compression Implant SystemTreace Medical ConceptsK242415TMC Compression Implant SystemTreace Medical Concepts

Official Source

View on FDA Database →

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

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