510(k) Premarket Notification

• Device Classification Name: filler, bone void, calcium compound
• 510(K) Number: K121989
• Model: 650-01-05, 01, -02, -05, -10, -20, 652-00-01, -02, -05, -10, -20
• Device Name: OPTECURE BONE VOID FILLER (0.5 CC, 1CC, 2CC, 5CC, 10CC, AND 20CC), OPTECURE + CCC BONE VOID FILLER (1CC, 2CC, 5CC, 10CC,
• Applicant: EXACTECH, INC.; 2320 n.w. 66th ct.; gainesville, FL 32653
• Contact: gina cassidy
• Regulation Number: 888.3045
• Classification Product Code: MQV
• Subsequent Product Code: MBP
• Date Received: 07/06/2012
• Decision Date: 11/27/2012
• 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