510(k) Premarket Notification

• Device Classification Name: intervertebral fusion device with bone graft, cervical
• 510(K) Number: K122518
• Device Name: SYNSTER (CERVICAL,ALIF, PLIF, PTLIF AND TLIF) CAGE HERA CERVICAL CAGE RHEA PLIF CAGE TALON TIFA CAGE
• Applicant: BM KOREA CO., LTD.; 951 starbuck st. unit j; fullerton, CA 92833
• Contact: priscilla chung
• Regulation Number: 888.3080
• Classification Product Code: ODP
• Subsequent Product Code: MAX
• Date Received: 08/17/2012
• Decision Date: 02/15/2013
• 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