510(k) Premarket Notification

• Device Classification Name: orthosis, spinal pedicle fixation
• 510(K) Number: K120099
• Device Name: RANGE SPINAL SYSTEM (MESA AND DENALI)
• Applicant: K2M, INC.; 751 miller dr.,se; leesburg, VA 20175
• Contact: nancy giezen
• Regulation Number: 888.3070
• Classification Product Code: MNI
• Subsequent Product Codes: KWP MNH
• Date Received: 01/12/2012
• Decision Date: 05/18/2012
• 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