510(k) Premarket Notification

• Device Classification Name: orthosis, spinal pedicle fixation, for degenerative disc disease
• 510(K) Number: K111099
• Device Name: ISSYS LP SPINAL FIXATION SYSTEM
• Applicant: CUSTOM SPINE, INC.; 1140 parsippany blvd.; suite 201; parsippany, NJ 07054
• Contact: saad attiyah
• Regulation Number: 888.3070
• Classification Product Code: NKB
• Subsequent Product Codes: KWP KWQ MNH MNI
• Date Received: 04/20/2011
• Decision Date: 05/05/2011
• 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