510(k) Premarket Notification

• Device Classification Name: orthosis, spinal pedicle fixation, for degenerative disc disease
• 510(k) Number: K042953
• Device Name: MODIFICATION TO PROTEX STABILIZATION SYSTEM
• Original Applicant: GLOBUS MEDICAL, INC.; 303 schell lane; phoenixville, PA 19460
• Original Contact: kelly j baker
• Regulation Number: 888.3070
• Classification Product Code: NKB
• Subsequent Product Codes: KWP KWQ MNH MNI
• Date Received: 10/26/2004
• Decision Date: 11/22/2004
• Decision: substantially equivalent (SESE)
• Regulation Medical Specialty: Orthopedic
• 510k Review Panel: Orthopedic
• summary: summary
• Type: Special
• Reviewed by Third Party: No
• Combination Product: No