Humanitarian Device Exemption (HDE)

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

• Trade Name: METACARPAL PHALANGEAL JOINT IMPLANT
• Applicant: Encore Medical L/P. D/B/A Djo Surgical; 9800 metric blvd.; austin, TX 78758
• HDE Number: H010001
• Supplement Number: S002
• Date Received: 08/24/2007
• Decision Date: 09/28/2007
• Advisory Committee: Orthopedic
• Supplement Type: 30-day notice
• Supplement Reason: location change - manufacturer/sterilizer/packager/supplier
• Expedited Review Granted?: No
• Combination Product: No