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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 K251945
Device Name TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)
Applicant
TriMed, Inc.
27533 Ave. Hopkins
Santa Clarita,  CA  91355
Applicant Contact Blesson Abraham
Correspondent
Tech2med, LLC
6450 Old Darby Trl. NE
Ada,  MI  49301
Correspondent Contact David Anderson
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received06/25/2025
Decision Date 07/10/2025
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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