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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intervertebral Fusion Device With Bone Graft, Cervical
510(k) Number K182284
Device Name Tyber Medical PT Interbody Spacer
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 Number888.3080
Classification Product Code
ODP  
Date Received08/23/2018
Decision Date 01/18/2019
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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