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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 K120293
Model MULTIPLE
Device Name SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DRIVE
Applicant
SPINEOLOGY, INC.
7800 3rd st n., suite 600
st. paul,  MN  55128
Contact bryan becker
Regulation Number888.3080
Classification Product Code
MAX  
Date Received01/31/2012
Decision Date 02/29/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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