Neurostructures CORTINA™ Lumbar Cage System

Vendor/Manufacturer: Neurostructures, Inc.

Product/Product Line: CORTINA™ Lumbar Cage System

FDA Regulation Medical Specialty: Orthopedic Devices - Prosthetic Devices

FDA Regulation Number: 888.3080

FDA Regulation Description Classification Name:

Intervertebral Body Fusion Device

FDA Classification Product Code: MAX

FDA Classification Product Code Device Name:

Intervertebral Fusion Device With Bone Graft, Lumbar

SUBSTANTIALLY EQUIVALENT to the following products:

1. Eisertech PLIF Cage

2. Synthes OPAL Spacer

3. Stryker AccuLIF® TL and PL Cage

4. Spinal Element Lucent Cage

5. CoAlign Innovations AccuLiF® TL-PEEK Cage

6. CoAlign Innovations AccuLiF® TL and P

Device Description:

The Cortina™ Lumbar Cage System is an intervertebral fusion device made from medical grade PEEK with titanium markers. The subject device is offered in a variety of styles and sizes to accommodate various patient anatomies.

Indications for Use:

The Cortina™ Lumbar Cage System is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The interior of the Cortina™ Lumbar Cage System should be packed with autogenous bone graft (i.e. autograft). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of nonoperative treatment.