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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K254002
Device Name TriMed Volar Bearing Plates (VBEAL-13-7S); TriMed Volar Bearing Plates (VBEAR-13-7S); TriMed Volar Bearing Plates (VBEAL-14-7S); TriMed Volar Bearing Plates (VBEAR-14-7S); TriMed Volar Bearing Plates (VBEAL-16-7S); TriMed Volar Bearing Plates (VBEAR-16-7S)
Applicant
TriMed, Inc.
27533 Ave. Hopkins
Santa Clarita,  CA  91355
Applicant Contact Sneha Potlapally
Correspondent
TriMed, Inc.
27533 Ave. Hopkins
Santa Clarita,  CA  91355
Correspondent Contact Sneha Potlapally
Regulation Number888.3030
Classification Product Code
HRS  
Date Received12/15/2025
Decision Date 01/15/2026
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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