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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
Contact mark bekkala
Regulation Number888.3060
Classification Product Code
MQP  
Date Received02/27/2012
Decision Date 04/05/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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