NuVasive® Lumbar Interbody Implants

K153782MAX3/24/2016

Applicant

NUVASIVE, INCORPORATED

Intended Use

The implants are designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and supplemental internal spinal fixation system cleared by the FDA for use in the lumbosacral spine.

Indications for Use

The NuVasive Lumbar Non-Interfixated Interbody Implants are indicated for intervertebral body fusion of the spine in skeletally mature patients. The devices are to be used in patients who have had at least six months of non-operative treatment. The Lumbar Non-Interfixated Interbody Implants (L and XL platforms) are intended for use at either one level or two contiguous levels in the lumbar spine (L2-S1) for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis.

Predicate Devices

  • K143163 - Stryker Spine AVS™ AL and AVS™ ALign PEEK Spacers, AVS™ PL and AVS™ UniLIF PEEK Spacers, AVS™ TL PEEK Spacer, AVS™ Navigator PEEK Spacer, AVS™ ARIA PEEK Spacer, AccuLIF TL and PL Cage, AVS™ Anchor-L Spacer, and Aero™-AL Lumbar Cage System (MAX)
  • K141665 - CoRoent System (MAX)
  • K140319 - CoRoent Ti-C System (MAX)