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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 K163481
Device Name HALF DOME Posterior Lumbar Interbody System
Applicant
Astura Medical
5670 El Camino Real
Suite B
Carlsbad,  CA  92008
Applicant Contact Troy Taylor
Correspondent
Astura Medical
5670 El Camino Real
Suite B
Carlsbad,  CA  92008
Correspondent Contact Troy Taylor
Regulation Number888.3080
Classification Product Code
MAX  
Date Received12/12/2016
Decision Date 05/03/2017
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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