510(k) Premarket Notification

• Device Classification Name: pedicle screw spinal system, adolescent idiopathic scoliosis
• 510(K) Number: K121630
• Device Name: RANGE SPINAL SYSTEM
• Applicant: K2M, INC.; 751 miller dr., s.e., suite f1; leesburg, VA 20175
• Contact: nancy giezen
• Regulation Number: 888.3070
• Classification Product Code: OSH
• Subsequent Product Codes: KWP MNH MNI
• Date Received: 06/04/2012
• Decision Date: 09/11/2012
• 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