510(k) Premarket Notification

• Device Classification Name: cement, bone, vertebroplasty
• 510(K) Number: K113742
• Model: FG0001, FG0002, FG0003, FG0004
• Device Name: KMC KYPHOPLASTY SYSTEM
• Applicant: SHANGHAI KINETIC MEDICAL CO., LTD; 3924cascade beach road; lutsen, MN 55612
• Contact: gregory mathison
• Regulation Number: 888.3027
• Classification Product Code: NDN
• Subsequent Product Code: HRX
• Date Received: 12/21/2011
• Decision Date: 09/17/2012
• 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