510(k) Premarket Notification

• Device Classification Name: orthosis, spinal pedicle fixation, for degenerative disc disease
• 510(K) Number: K122845
• Model: 48280XXXX
• Device Name: ES2 SPINAL SYSTEM MODEL 48280XXXX
• Applicant: STRYKER SPINE; 2 pearl court; allendale, NJ 07401
• Contact: soraya king
• Regulation Number: 888.3070
• Classification Product Code: NKB
• Subsequent Product Codes: KWP MNH MNI
• Date Received: 09/17/2012
• Decision Date: 12/07/2012
• 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