Premarket Approval (PMA)

Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.

• Trade Name: RAY THREADED FUSION CAGE (TFC)
• Classification Name: intervertebral fusion device with bone graft, lumbar
• Generic Name: interbody fusion device
• Regulation Number: 888.3080
• Applicant: HOWMEDICA OSTEONICS CORP.
• PMA Number: P950019
• Supplement Number: S015
• Date Received: 07/28/2003
• Decision Date: 09/04/2003
• Product Code: MAX [ Registered Establishments with MAX ]
• Advisory Committee: Orthopedic
• Supplement Type: Special Supplement
• Supplement Reason: labeling change - minor
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval for labeling changes and changes in part numbers.