LDR SPINE ROI-A INTERBODY FUSION SYSTEM

K110327OVD9/30/2011

Applicant

LDR SPINE USA

Intended Use

The ROI- A Oblique implant is intended for use as an interbody fusion device in the lumbar spine.

Indications for Use

When used as an intervertebral body fusion device, the ROI-A Implant System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

Predicate Devices