510(k) Premarket Notification

• Device Classification Name: orthosis, spinal pedicle fixation, for degenerative disc disease
• 510(K) Number: K121342
• Device Name: XIA 4.5 SPINAL SYSTEM
• Applicant: STRYKER CORP; 2 pearl court; allendale, NJ 07401
• Contact: tiffani rogers
• Regulation Number: 888.3070
• Classification Product Code: NKB
• Subsequent Product Codes: KWP KWQ MNH MNI OSH
• Date Received: 05/04/2012
• Decision Date: 06/22/2012
• Decision: substantially equivalent - with limitations (SU)
• Classification Advisory Committee: Orthopedic
• Review Advisory Committee: Orthopedic
• summary: summary
• Type: Traditional
• Reviewed by Third Party: No
• Expedited Review: No
• Combination Product: No