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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 K160982
Device Name Sphynx™
Applicant
Eden Spine, LLC
377 Maitland Ave., Suite 1015
Atlamonte Springs,  FL  32701
Applicant Contact Guillaume Viallaneix
Correspondent
Novus Management Group, LLC
6686 Dimmick Rd.
West Chester,  OH  45069
Correspondent Contact Tamala J. Wampler
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received04/07/2016
Decision Date 12/22/2016
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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