510(k) Premarket Notification

• Device Classification Name: intervertebral fusion device with bone graft, cervical
• 510(K) Number: K122872
• Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Applicant: DIO MEDICAL CO., LTD.; 325 n. puente st; unit b; brea, CA 92821
• Contact: april lee
• Regulation Number: 888.3080
• Classification Product Code: ODP
• Subsequent Product Code: MAX
• Date Received: 09/19/2012
• Decision Date: 02/28/2013
• 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