510(k) Premarket Notification

• 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
• Contact: saeyoung ahn
• Regulation Number: 888.3070
• Classification Product Code: MNI
• Subsequent Product Code: MNH
• Date Received: 06/01/2012
• 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