510(k) Premarket Notification

• Device Classification Name: appliance, fixation, spinal intervertebral body
• 510(K) Number: K121060
• Device Name: SPINE FRONTIER INDUS ACP SYSTEM
• Applicant: SPINEFRONTIER, INC.; 500 cummings center; suite 3500; beverly, MA 01915
• Contact: fredy h varela
• Regulation Number: 888.3060
• Classification Product Code: KWQ
• Date Received: 04/06/2012
• Decision Date: 07/03/2012
• 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