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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 K243987
Device Name TriMed Elbow and Forearm System
Applicant
TriMed, Inc.
275333 Ave. Hopkins
Santa Clarita,  CA  91355
Applicant Contact Mikayla German
Correspondent
TriMed, Inc.
275333 Ave. Hopkins
Santa Clarita,  CA  91355
Correspondent Contact Mikayla German
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Codes
HWC   NDG   NDL  
Date Received12/23/2024
Decision Date 03/19/2025
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		 Yes
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