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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 K232652
Device Name Anatomical Plating System (various)
Applicant
Tyber Medical, LLC
83 S. Commerce Way, Suite 310
Bethlehem,  PA  18017
Applicant Contact Lisa Boyle
Correspondent
Tyber Medical, LLC
83 S. Commerce Way, Suite 310
Bethlehem,  PA  18017
Correspondent Contact Lisa Boyle
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received08/31/2023
Decision Date 12/13/2023
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
Recalls CDRH Recalls
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