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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 K192975
Device Name Tyber Medical Trauma Screws
Applicant
Tyber Medical LLC
83 South Commerce Way
Bethlehem,  PA  18017
Applicant Contact Mark Schenk
Correspondent
Tyber Medical LLC
83 South Commerce Way
Bethlehem,  PA  18017
Correspondent Contact Jessica Stigliano
Regulation Number888.3040
Classification Product Code
HWC  
Date Received10/24/2019
Decision Date 01/09/2020
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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