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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Finger, Constrained, Polymer
510(k) Number K263582
Device Name KeriFlex® MCP and PIP Finger Joint Prostheses
Applicant
Keri Medical SA
Chemin Du Pré-Fleuri, 5
Plan-Les-Ouates,  CH 1228
Applicant Contact Camille Miletto
Correspondent
MCRA, LLC
803 7th St. NW
Washington, Dc,  DC  20001
Correspondent Contact Sarah Pleaugh
Regulation Number888.3230
Classification Product Code
KYJ  
Date Received09/30/2026
Decision Date 10/29/2026
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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