510(k) Premarket Notification

• Device Classification Name: appliance, fixation, spinal interlaminal
• 510(K) Number: K971289
• Device Name: SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM)
• Applicant: OSTEOTECH, INC.; 51 james way; eatontown, NJ 07724
• Contact: christopher talbot
• Regulation Number: 888.3050
• Classification Product Code: KWP
• Subsequent Product Code: MNH
• Date Received: 04/07/1997
• Decision Date: 06/18/1997
• 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