FDA Approval Letters and Safety & Effectiveness Data: Cervical & Lumbar Artificial Disc Replacement Devices

[Justin]

BRYAN® Cervical Disc

• Here's information on the FDA approval of the BRYAN® Cervical Disc on 5/12/09. Click here.
  
• Here's a PDF of the actual Approval Letter of the BRYAN® Cervical Disc from the FDA. Click here.
  
• Summary of Safety and Effectiveness Data. Click here.

CHARITÉ™ Artificial Disc

• Here's information on the FDA approval of the CHARITÉ™ from 2004. Click here.
  
• Here's a PDF of the actual Approval Letter of the CHARITÉ™ from the FDA. Click here.
  
• Summary of Safety and Effectiveness Data. Click here.

PRESTIGE® Cervical Disc System

• Here's information on the FDA approval of the PRESTIGE® Cervical Disc from 2006. Click here.
  
• Here's a PDF of the actual Approval Letter of the PRESTIGE® Cervical Disc from the FDA. Click here.
  
• Summary of Safety and Effectiveness Data. Click here.

ProDisc®-L Total Disc Replacement

• Here's information on the FDA approval of the ProDisc®-L from 2006. Click here.
  
• Here's a PDF of the actual Approval Letter of the ProDisc®-L from the FDA. Click here.
  
• Summary of Safety and Effectiveness Data. Click here.

ProDisc®-C Total Disc Replacement

• Here's information on the FDA approval of the ProDisc®-C from 2007. Click here.
  
• Here's a PDF of the actual Approval Letter of the ProDisc®-C from the FDA. Click here.
  
• Summary of Safety and Effectiveness Data. Click here.

[dancen1]

BRYAN® Cervical Disc

• Here's information on the FDA approval of the BRYAN® Cervical Disc on 5/12/09. Click here.
  
• Here's a PDF of the actual Approval Letter of the BRYAN® Cervical Disc from the FDA. Click here.
  
• Summary of Safety and Effectiveness Data. Click here.

CHARITÉ™ Artificial Disc

• Here's information on the FDA approval of the CHARITÉ™ from 2004. Click here.
  
• Here's a PDF of the actual Approval Letter of the CHARITÉ™ from the FDA. Click here.
  
• Summary of Safety and Effectiveness Data. Click here.

PRESTIGE® Cervical Disc System

• Here's information on the FDA approval of the PRESTIGE® Cervical Disc from 2006. Click here.
  
• Here's a PDF of the actual Approval Letter of the PRESTIGE® Cervical Disc from the FDA. Click here.
  
• Summary of Safety and Effectiveness Data. Click here.

ProDisc®-L Total Disc Replacement

• Here's information on the FDA approval of the ProDisc®-L from 2006. Click here.
  
• Here's a PDF of the actual Approval Letter of the ProDisc®-L from the FDA. Click here.
  
• Summary of Safety and Effectiveness Data. Click here.

ProDisc®-C Total Disc Replacement

• Here's information on the FDA approval of the ProDisc®-C from 2007. Click here.
  
• Here's a PDF of the actual Approval Letter of the ProDisc®-C from the FDA. Click here.
  
• Summary of Safety and Effectiveness Data. Click here.

Have you seen anything on XL TDR FDA approval?


XL TDR is a metallic prosthetic joint, or total disc replacement, that replaces a degenerative intervertebral disc. Like fusion, total disc replacement is designed to supplant the primary function of the disc – to maintain vertebral spacing to protect the nerves and spinal cord. Unlike fusion, though, total disc replacement seeks to maintain one of the secondary functions of the disc – providing motion in the spine. Once implanted between the vertebrae, XL TDR is designed to relieve pain and restore height while replicating the motion characteristics of an intact healthy disc.

[sportsnut3007]

Good luck with the surgery!! The lateral approach from what I read is alot better than anterior approach. I think the future is this approach with all ADR's.