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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K243943
Device Name TriMed® Compression Screws
Applicant
TriMed, Inc.
27533 Avenue Hopkins
Santa Clarita,  CA  91355
Applicant Contact Thomas Arnold
Correspondent
TriMed, Inc.
27533 Avenue Hopkins
Santa Clarita,  CA  91355
Correspondent Contact Thomas Arnold
Regulation Number888.3040
Classification Product Code
HWC  
Date Received12/20/2024
Decision Date 04/10/2025
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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