510(k) Premarket Notification

• Device Classification Name: fastener, fixation, biodegradable, soft tissue
• 510(K) Number: K122869
• Model: 5X12MM, 6X12MM
• Device Name: MILAGRO INTERFERENCE SCREWS
• Applicant: DEPUY MITEK, A JOHNSON & JOHNSON COMPANY; 325 paramount dr.; raynham, MA 02767
• Contact: kristine christo
• Regulation Number: 888.3030
• Classification Product Code: MAI
• Subsequent Product Code: HWC
• Date Received: 09/19/2012
• Decision Date: 12/13/2012
• 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