510(k) Premarket Notification

• Device Classification Name: orthosis, spinal pedicle fixation, for degenerative disc disease
• 510(K) Number: K120355
• Device Name: LEUCADIA 4.5 MM PEDICLE SCREW SYSTEM
• Applicant: PHYGEN, LLC; 2301 dupont drive, suite 510; irvine, CA 92612
• Contact: hartmut loch
• Regulation Number: 888.3070
• Classification Product Code: NKB
• Subsequent Product Codes: KWP KWQ MNH MNI
• Date Received: 02/06/2012
• Decision Date: 03/07/2012
• 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