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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Intervertebral Body
510(k) Number K160522
Device Name White Pearl Preferred Angle Anterior Cervical Plate
Applicant
Osseus Fusion Systems, LLC
2703 Mockingbird Ln., 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 Number888.3060
Classification Product Code
KWQ  
Date Received02/25/2016
Decision Date 04/26/2016
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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