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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
510(k) Number K120570
Device Name CHOICE SPINE VERTEBRAL BODY REPLACEMENT (VBR) DEVICE SYSTEM
Applicant
CHOICE SPINE, LP
400 Erin Dr
KNOXVILLE,  TN  37919
Applicant Contact MARK BEKKALA
Correspondent
CHOICE SPINE, LP
400 Erin Dr
KNOXVILLE,  TN  37919
Correspondent Contact MARK BEKKALA
Regulation Number888.3060
Classification Product Code
MQP  
Date Received02/27/2012
Decision Date 04/05/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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