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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name orthosis, spinal pedicle fixation
510(k) Number K121615
Device Name 4CIS VANE SPINE SYSTEM
Original Applicant
SOLCO BIOMEDICAL CO., LTD.
9700 great seneca highway
ste 302
rockville,  MD  20850
Original Contact saeyoung ahn
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Code
MNH  
Date Received06/01/2012
Decision Date 08/15/2012
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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