SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers, INDEPENDENCE TPS Spacer, FORTIFY -R TPS Corpectomy Spacer, FORTIFY I-R TPS Corpectomy Spacer, XPand -R TPS Corpectomy Spacer, NIKO TPS Corpectomy Spacer

K143578MAX4/13/2016

Applicant

GLOBUS MEDICAL INC.

Intended Use

The devices are intended for use as intervertebral body fusion devices and/or vertebral body replacement devices depending on the specific model. They provide structural stability in skeletally mature individuals following discectomy, corpectomy, or vertebrectomy.

Indications for Use

The devices are indicated for use in patients with degenerative disc disease (DDD) at various spinal levels depending on the specific model. They are used in skeletally mature patients who have had non-operative treatment. The devices are to be filled with autogenous bone graft material and used with supplemental fixation.

Predicate Devices

  • K133967 - Aurora Spine Interbody Fusion System (MAX)