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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 K181347
Device Name Aries® Lumbar Interbodies
Applicant
Osseus Fusion Systems, LLC
2703 Mockingbird Lane, Suite 102
Dallas,  TX  75235
Applicant Contact Robert Pace
Correspondent
The OrthoMedix Group, Inc.
1001 Oakwood Blvd.
Round Rock,  TX  78681
Correspondent Contact J. D. Webb
Regulation Number888.3080
Classification Product Code
MAX  
Date Received05/21/2018
Decision Date 08/15/2018
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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