Cleared Special

COGNiTiON? Staple System

K240212 · Ortho Solutions UK , Ltd. · Orthopedic

Feb 2024

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K240212 is an FDA 510(k) clearance for the COGNiTiON? Staple System, a Staple, Fixation, Bone (Class II — Special Controls, product code JDR), submitted by Ortho Solutions UK , Ltd. (Maldon, GB). The FDA issued a Cleared decision on February 23, 2024, 29 days after receiving the submission on January 25, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K240212 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 25, 2024
Decision Date	February 23, 2024
Days to Decision	29 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF