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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K260115
Device Name DRIM-Nail System
Applicant
41Medical AG
Tannlimattweg 14
Bettlach,  CH 2544
Applicant Contact Alfred Niederberger
Correspondent
Mcra, LLC
803 7th St. NW
Washington,  DC  20001
Correspondent Contact Sarah Pleaugh
Date Received01/14/2026
Decision Date 09/11/2026
Decision Substantially Equivalent (SESE)
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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