NuVasive Vertera Spine™ Cohere® Cervical Interbody Fusion Device

Vendor/Manufacturer: NuVasive, Incorporated

Product/Product Line: Vertera Spine™ Cohere® Cervical Interbody Fusion Device

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: ODP

FDA Classification Product Code Device Name:

Intervertebral Fusion Device With Bone Graft, Cervical

SUBSTANTIALLY EQUIVALENT to the following products:

1. NuVasive CoRoent Small Interbody System

2. NuVasive Vertera Hedgehog Cervical Interbody Fusion Device

Device Description:

The subject Vertera Spine Cohere Cervical Interbody Fusion Device, previously cleared as predicate Vertera Hedgehog Cervical Interbody Fusion Device (K143685), is an interbody fusion device comprised of a single, continuous piece of PEEK Scoria®, which is formed into a final product shape.

The subject device remains solid with an extruded porous layer on the superior and inferior surfaces of the implant body. The porous surface is derived directly from the implant body and is not a sintered or otherwise additive coating. The hollow core or graft aperture allows for packing of autograft or allograft to help promote a solid fusion. The PEEK cage contains two marker bands made of tantalum conforming to ASTM F560 R05200, which serve as radiopaque markers so the location and orientation of the device may be seen radiographically, during and after the procedure for position confirmation.

The Vertera Spine Cohere Cervical Interbody Fusion Device comes in a variety of sizes and geometries to suit the individual pathology and anatomical conditions of the patient. The devices are provided sterile, with the accessory surgical instruments packaged as non-sterile to be sterilized by the end user. The Vertera Spine Cohere Cervical Interbody Fusion Device is intended to be used with supplemental fixation.

Indications for Use:

The Vertera Spine™ Cohere® Cervical Interbody Fusion Device is indicated for intervertebral body fusion of the spine in skeletally mature patients. The Vertera Spine Cohere Cervical Interbody Fusion Device is intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1.

The System is intended to be used with supplemental fixation. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft to facilitate fusion.