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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 Integrated Fixation, Cervical
510(k) Number K212612
Device Name Omnia Medical TiBrid-SC
Applicant
Omnia Medical, LLC
6 Canyon Road, Suite 300
Morgantown,  WV  26508
Applicant Contact Morgan Hill
Correspondent
Omnia Medical, LLC
6 Canyon Road, Suite 300
Morgantown,  WV  26508
Correspondent Contact Daniel Johnson
Regulation Number888.3080
Classification Product Code
OVE  
Date Received08/17/2021
Decision Date 11/15/2022
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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