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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
Applicant
SOLCO BIOMEDICAL CO., LTD.
9700 GREAT SENECA HIGHWAY
STE 302
ROCKVILLE,  MD  20850
Applicant Contact SAEYOUNG AHN
Correspondent
SOLCO BIOMEDICAL CO., LTD.
9700 GREAT SENECA HIGHWAY
STE 302
ROCKVILLE,  MD  20850
Correspondent 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 (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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