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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spinal Vertebral Body Replacement Device - Cervical
510(k) Number K191778
Device Name Omnia Medical VBR
Applicant
Omnia Medical, LLC
6 Canyon Rd., Suite 300
Morgantown,,  WV  26508
Applicant Contact Troy Schifano
Correspondent
Jalex Medical
30311 Clemens Rd. Suite 5d
Westlake,  OH  44145
Correspondent Contact Daniel Johnson
Regulation Number888.3060
Classification Product Code
PLR  
Subsequent Product Code
MQP  
Date Received07/02/2019
Decision Date 08/28/2019
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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