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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K203817
Device Name Tyber Medical Anatomical Plating System
Applicant
Tyber Medical, LLC
83 S Commerce Way
Bethlehem,  PA  18017
Applicant Contact Mark Schenk
Correspondent
Tyber Medical, LLC
83 S Commerce Way
Suite 310
Bethlehem,  PA  18017
Correspondent Contact Mark Schenk
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received12/29/2020
Decision Date 08/13/2021
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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