510(k) Premarket Notification

• Device Classification Name: intervertebral fusion device with bone graft, cervical
• 510(K) Number: K122850
• Device Name: TALOS-C CERVICAL INTERVERTEBRAL BODY FUSION DEVICES
• Applicant: MEDITECH ADVISORS, LLC; 200 nomer avenue; ashland, MA 01721
• Contact: sharyn orton
• Regulation Number: 888.3080
• Classification Product Code: ODP
• Date Received: 09/18/2012
• Decision Date: 03/28/2013
• Decision: substantially equivalent (SE)
• Classification Advisory Committee: Orthopedic
• Review Advisory Committee: Orthopedic
• statement: statement
• Type: Traditional
• Reviewed by Third Party: No
• Expedited Review: No
• Combination Product: No