SPACEVISION CAGE SYSTEM

K042930MQP12/28/2004

Applicant

SPINEVISION, INC.

Intended Use

The Spacevision cage implant is an oval shaped device with teeth on the upper and lower portions. The implant is hollow and can be used with bone graft when implanted. The implant is manufactured from PEEK Optima® LT1 and contains tantalum beads for location on radiographs. A variety of sizes are available, and the implants may be inserted individually or in pairs.

Indications for Use

The Spacevision™ Cage System is intended for use as partial replacement (i.e. partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body in the thoracolumbar spine (T1-L5). The Spacevision Cage System is also indicated in the treatment of trauma/fractures of the thoracic and lumbar spine.

Predicate Devices

  • K041888 - Tetris™ Spinal Implant (Signus Medizintechnik GMBH)
  • K040928 - Expandable PEEK VBR Implant (Interpore Cross International)
  • K042268 - EBI CAS Spine Spacer System (EBI, L.P.)
  • K003709 - Mesh Cage System (Surgical Dynamics™)