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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
510(k) Number K172323
Device Name Omnia Medical VBR
Applicant
Omnia Medical, LLC
1000 Hampton Center
Suite G
Morgantown,  WV  26505
Applicant Contact Troy Schifano
Correspondent
Jalex Medical
30311 Clemens Rd. Suite 5d
Westlake,  OH  44145
Correspondent Contact Kevin Majka
Regulation Number888.3060
Classification Product Code
MQP  
Date Received08/01/2017
Decision Date 10/26/2017
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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