510(k) Premarket Notification

• Device Classification Name: intervertebral fusion device with bone graft, lumbar
• 510(K) Number: K120918
• Device Name: NUVASIVE COROENT TITANIUM SYSTEM
• Applicant: NUVASIVE, INC.; 7475 lusk blvd; san diego, CA 92121
• Contact: sheila bruschi
• Regulation Number: 888.3080
• Classification Product Code: MAX
• Subsequent Product Code: MQP
• Date Received: 03/27/2012
• Decision Date: 06/28/2012
• 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