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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spinal Vertebral Body Replacement Device - Cervical
510(k) Number K152568
FOIA Releasable 510(k) K152568
Device Name C-VBR
Applicant
Cardinal Spine, LLC
12307 Old La Grange Rd.
Suite 105
Louisville,  KY  40245
Applicant Contact NATASHA LONNON
Correspondent
PaxMed International, LLC
12264 El Camino Real
Suite 400
San Diego,  CA  92130
Correspondent Contact KEVIN A THOMAS
Regulation Number888.3060
Classification Product Code
PLR  
Date Received09/09/2015
Decision Date 02/11/2016
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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