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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K251732
Device Name Wrist Fracture System
Applicant
Met One Technologies, LLC
4519 Osborne Dr., Suite C
El Paso,  TX  79922
Applicant Contact Evan Carbonell
Correspondent
Met One Technologies, LLC
4519 Osborne Dr., Suite C
El Paso,  TX  79922
Correspondent Contact Liberato Aguilar
Date Received06/06/2025
Decision Date 02/12/2026
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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