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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 K243569
Device Name TriMed Wrist Fixation System (Volar Bearing Plates); TriMed Wrist Fixation System (Volar Fixed Angle Plates); TriMed Wrist Fixation System (Hook Plates); TriMed Wrist Fixation System (Pin Plates); TriMed Wrist Fixation System (Peg Plates); TriMed Wrist Fixation System (Shear Plates); TriMed Wrist Fixation System (Wireform plates and Washer); TriMed Wrist Fixation System (Wireforms); TriMed Wrist Fixation System (Torx Cortical Screws); TriMed Wrist Fixation System (Torx Threaded Pegs);
Applicant
TriMed, Inc.
27533 Ave. Hopkins
Santa Clarita,  CA  91355
Applicant Contact Divya Raghavi Nandakumar
Correspondent
TriMed, Inc.
27533 Ave. Hopkins
Santa Clarita,  CA  91355
Correspondent Contact Divya Raghavi Nandakumar
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Codes
HWC   NDG   NDL  
Date Received11/18/2024
Decision Date 01/15/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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