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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 K152512
Device Name Half Dome Posterior Lumbar Interbody System
Applicant
Astura Medical
5670 El Camino Real
Suite B
Carlsbad,  CA  92008
Applicant Contact Thomas Astura
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 Received09/02/2015
Decision Date 01/28/2016
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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