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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pin, Fixation, Smooth
510(k) Number K262126
Device Name Cerclage Wires;K-wires;Steinmann Pins
Applicant
MK Medical GmbH
Jahnstraße 14
Emmingen-Liptingen,  DE 78576
Applicant Contact Jakob Denzel
Correspondent
Medagent GmbH
Griesweg 47
Mühlheim An Der Donau,  DE 78570
Correspondent Contact Anaga Nayak
Regulation Number888.3040
Classification Product Code
HTY  
Subsequent Product Codes
JDQ   JDW  
Date Received06/24/2026
Decision Date 10/22/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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