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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Intraosseous
510(k) Number K250123
Device Name Master-Pin X (MP Pin with thread) (36BMP000030 / MP30)
Applicant
Hager& Meisinger GmbH
Hansemannstr. 10
Neuss,  DE 41468
Applicant Contact Wiebke Eckhardt
Correspondent
Hager& Meisinger GmbH
Hansemannstr. 10
Neuss,  DE 41468
Correspondent Contact Wiebke Eckhardt
Regulation Number872.4880
Classification Product Code
DZL  
Date Received01/17/2025
Decision Date 09/29/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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