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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Wedge
510(k) Number K171327
Device Name Tyber Medical Wedge System
Applicant
Tyber Medical, LLC
83 S. Commerce Way, Suite 310
Bethlehem,  PA  18017
Applicant Contact Mark F. Schenk
Correspondent
Tyber Medical, LLC
83 S. Commerce Way, Suite 310
Bethlehem,  PA  18017
Correspondent Contact Mark F. Schenk
Regulation Number888.3030
Classification Product Code
PLF  
Subsequent Product Codes
HRS   HWC  
Date Received05/05/2017
Decision Date 05/16/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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