Device Recall SpineNet Anterior Cervical Cage

  • Model / Serial
    Ref. No. CL1012-05 Size 10mm x 12mm x 5mm, Ref. No. CL1012-06 Size 10mm x 12mm x 6mm, Ref. No. CL1012-07 Size 10mm x 12mm x 7mm, Ref. No. CL1012-08 Size 10mm x 12mm x 8mm, Ref. No. CL1012-09 Size 10mm x 12mm x 9mm, Ref. No. CL1012-10 Size 10mm x 12mm x 10mm, Ref. No. CL1014-05 Size 12mm x 14mm x 5mm, Ref. No. CL1014-06 Size 12mm x 14mm x 6mm, Ref. No. CL1014-07 Size 12mm x 14mm x 7mm, Ref. No. CL1014-08 Size 12mm x 14mm x 8mm, Ref. No. CL1014-09 Size 12mm x 14mm x 9mm, and Ref. No. CL1014-10 Size 12mm x 14mm x 10mm.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    USA Nationwide Distribution in the state of Florida
  • Product Description
    SpineNet Anterior Cervical Cage, Lordotic, Peek (originally submitted as Daytona Anterior Cervical Cage) || Product Usage: Is indicated for use in skeletally mature patients with degenerative disc disease of the cervical spine with accompanying radicular symptoms at one disc level
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    SpineNet, 1300 Minnesota Ave, Suite 200, Winter Park FL 32789-4800
  • Manufacturer Parent Company (2017)
  • Source
    USFDA