510(k) Premarket Notification

• Device Classification Name: filler, bone void, calcium compound
• 510(K) Number: K122868
• Models: BPY-005, BPY-025, BPY-100
• Device Name: BIOSPHERE BIOACTIVE BONE GRAFT PUTTY, 2.5CC BIOSPHERER BIOACTIVE BONE GRAFT PUTTY, 5CC
• Applicant: SYNERGY BIOMEDICAL, LLC; 555 thirteenth street, nw; washington, DC 20009
• Contact: randy prebula
• Regulation Number: 888.3045
• Classification Product Code: MQV
• Date Received: 09/18/2012
• Decision Date: 04/19/2013
• 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