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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, Cervical
510(k) Number K143685
Device Name Hedgehog Cervical Interbody Fusion Device
Applicant
Vertera, Inc.
311 Ferst Dr., NW
Suite L1328
Atlanta,  GA  30332
Applicant Contact Stephen Laffoon
Correspondent
Vertera, Inc.
311 Ferst Dr., NW
Suite L1328
Atlanta,  GA  30332
Correspondent Contact Stephen Laffoon
Regulation Number888.3080
Classification Product Code
ODP  
Date Received12/24/2014
Decision Date 09/23/2015
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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