NuVasive® Interfixated Interbody System

K160051OVD4/20/2016

Applicant

NuVasive, Incorporated

Intended Use

The NuVasive® Interfixated Interbody System consists of two systems: The CoRoent XL-F System and Brigade System, both indicated for spinal fusion procedures in skeletally mature patients. The systems are designed for use with autogenous bone graft to facilitate fusion.

Indications for Use

The system is indicated for intervertebral body fusion of the spine in skeletally mature patients, for use in the lumbar spine from L2 to S1/L5, following discectomy in the treatment of symptomatic degenerative disc disease (DDD) with up to Grade I spondylolisthesis at one or two adjacent levels. The devices can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.

Predicate Devices

  • K140479 - NuVasive CoRoent XL-F System (OVD)
  • K131723 - NuVasive CoRoent Single Tab System (OVD)
  • K100043 - CoRoent XLR Standalone System (OVD)
  • K123045 - Brigade Hyperlordotic System (OVD)
  • K153419 - CoRoent Thoracolumbar System (OVD)