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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 K253042
Device Name Tyber Medical Trauma Screw
Applicant
Tyber Medical, LLC
83 S. Commerce Way, Suite 310
Bethlehem,  PA  18017
Applicant Contact Nicole Merlini
Correspondent
Tyber Medical, LLC
83 S. Commerce Way, Suite 310
Bethlehem,  PA  18017
Correspondent Contact Nicole Merlini
Regulation Number888.3040
Classification Product Code
HWC  
Date Received09/22/2025
Decision Date 04/03/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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