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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, Lumbar
510(k) Number K183659
Device Name Omnia Medical Rotary PLIF System
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 Number888.3080
Classification Product Code
MAX  
Date Received12/27/2018
Decision Date 02/06/2019
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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