510(k) Premarket Notification

• Device Classification Name: posterior metal/polymer spinal system, fusion
• 510(K) Number: K031511
• Device Name: DYNESYS SPINAL SYSTEM
• Applicant: CENTERPULSE SPINE-TECH, INC.; 7375 bush lake rd.; minneapolis, MN 55439 2027
• Contact: angela byland
• Regulation Number: 888.3070
• Classification Product Code: NQP
• Date Received: 05/14/2003
• Decision Date: 03/05/2004
• Decision: substantially equivalent - with limitations (SU)
• Classification Advisory Committee: Orthopedic
• Review Advisory Committee: Orthopedic
• summary: summary
• Type: Traditional
• Reviewed by Third Party: No
• Expedited Review: No
• Combination Product: No