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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 K211783
Device Name TriMed Threaded Intramedullary Nail System
Applicant
TriMed, Inc.
27533 Avenue Hopkins
Santa Clarita,  CA  91355
Applicant Contact David Medoff
Correspondent
Tech2Med, LLC
6450 Old Darby TRL NE
Ada,  MI  49301
Correspondent Contact David Anderson
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
HSB  
Date Received06/09/2021
Decision Date 08/06/2021
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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