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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Staple, Fixation, Bone
510(k) Number K240212
Device Name COGNiTiON™ Staple System
Applicant
Ortho Solutions UK , Ltd.
West Station Business Park, Spital Rd., Unit 5
Maldon,  GB CM9 6FF
Applicant Contact Alex Faley
Correspondent
Ortho Solutions UK , Ltd.
West Station Business Park, Spital Rd., Unit 5
Maldon,  GB CM9 6FF
Correspondent Contact Alex Faley
Regulation Number888.3030
Classification Product Code
JDR  
Date Received01/25/2024
Decision Date 02/23/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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