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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 K261241
Device Name TriMed Compression Screws
Applicant
TriMed, Inc.
27533 Ave. Hopkins
Santa Clarita,  CA  91355
Applicant Contact Annika Lind
Correspondent
TriMed, Inc.
27533 Ave. Hopkins
Santa Clarita,  CA  91355
Correspondent Contact Annika Lind
Regulation Number888.3040
Classification Product Code
HWC  
Date Received04/15/2026
Decision Date 05/14/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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