510(k) Premarket Notification

• Device Classification Name: orthosis, spondylolisthesis spinal fixation
• 510(K) Number: K061162
• Device Name: BAR PEDICLE SCREW SPINAL FIXATION SYSTEM, MODEL 2020
• Applicant: APPLIED SPINE TECHNOLOGIES, INC.; 300 george st.; suite 511; new haven, CT 06511
• Contact: michele lucey
• Regulation Number: 888.3070
• Classification Product Code: MNH
• Subsequent Product Code: MNI
• Date Received: 04/26/2006
• Decision Date: 07/26/2006
• 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