510(k) Premarket Notification

• Device Classification Name: plate, fixation, bone
• 510(K) Number: K122005
• Model: MXL
• Device Name: MAXLOCK EXTREME SYSTEM
• Applicant: ORTHOHELIX SURGICAL DESIGNS, INC.; 1065 medina rd.; suite 500; medina, OH 44256
• Contact: derek lewis
• Regulation Number: 888.3030
• Classification Product Code: HRS
• Subsequent Product Code: HWC
• Date Received: 07/09/2012
• Decision Date: 09/06/2012
• 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