510(k) Premarket Notification

• Device Classification Name: orthosis, spinal pedicle fixation
• 510(K) Number: K991326
• Device Name: ISOBAR SEMI-RIGID SPINAL SYSTEM
• Applicant: SCIEN'TX USA INC.; 9800 metric blvd.; austin, TX 78758
• Contact: debbie de los santos
• Regulation Number: 888.3070
• Classification Product Code: MNI
• Subsequent Product Code: MNH
• Date Received: 04/19/1999
• Decision Date: 11/08/1999
• 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