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ACURA Stabilization System is intended to help provide immobilization of spinal segments in skeletally mature patients (including small stature) and for pediatric patients as an adjunct to fusion using posterior pedicle screw fixation (T1-S2/Ilium), posterior hook fixation (T1-L5), or anterolateral fixation. These devices are indicated as an adjunct to fusion for the treatment of the following acute and chronic spinal instabilities or deformities: 1. Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) 2. Degenerative spondylolisthesis 3. Trauma (fracture or dislocation) 4. Curvatures (Scoliosis, Kyphosis and /or Lordosis, Scheuermann's disease) 5. Spinal tumours 6. Spinal Stenosis 7. Pseudarthrosis 8. Previous Failed Fusions When used as an adjunct to fusion, ACURA Stabilization System is intended to be used with autograft and/or allograft. When used for posterior non-cervical pediation in pediatic patients, the ACURA Stabilization System is intended as an adjunct to fusion to treat adolescent idionathic scoliosis. Pediatric pedicle screw fixation is limited to a posterior approach.

The ACURA Stabilization System is a single use implantable system consisting of connecting members (rods) and fixation members (screws, hooks). The hooks are available in different types based on the attachment points on the vertebra such as the Lamina and Transverse Process. The screws are available in multiple diameters and lengths based on variations in the spinal anatomy. Variants in screws are also available based on the surgical procedure requirement such as polyaxial screws, monoaxial screws, uniplanar screws, cannulated screws, fenestrated screws, long tab screws, dual outer diameter screws. Locking caps are available which lock the screw head onto the rods. These devices can be rigidly locked into a variety of configurations as per surgical conditions and are available in a variety of sizes to accommodate individual patient anatomy. Screws mate with 5.5mm diameter rods. Screws, hooks and cross connectors are intended for posterior use only. Hooks are intended for posterior use only. Similarly, Screws, Rods and Cross-Connectors are intended for both posterior and lateral use. The devices are made Medical Grade Titanium (Ti6Al4V per ASTM F136), with some rods and polyaxial screw heads also offered as cobalt chromium alloy (Co28Cr6Mo per ASTM F1537). The safety and effectiveness of this device has not been established when used in conjunction with bone cement or for use in patients with poor bone quality (e.g., osteoporosis, osteopenia). This device is intended only to be used with saline or radiopaque dye.

The SEA-LINK Anterior Cervical Plate System is intended for temporary stabilization of the anterior cervical spine (C2-C7) during the development of cervical spinal fusion achieved through ACDF (Anterior Cervical Discectomy & Fusion) or corpectomy in patients with: • Degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) - ·Trauma (including fractures) - •Tumors - ·Deformity defined as kyphosis, lordosis or scoliosis •Pseudarthrosis - •Failed Previous Fusions - •Spondylolisthesis - •Spinal Stenosis

The SEA-LINK Anterior Cervical Plate System is a single use implantable device to assist in the stabilization of the cervical spine during cervical spinal fusion. The device consists of plates and bone screws and is designed to prevent the bone screws from backing out after implantation. The SEA-LINK Anterior Cervical Plate is designed to fit the lordosis of the cervical spine and to fit the curved medio - lateral anatomy of the spine. The SEA-LINK Anterior Cervical Plate System accommodates from single Level up to five-Level. The plate lengths range from 19mm to 114mm (end to end length) with a width and thickness of 17mm and 2.1mm respectively. The screws offered are of self-drilling and self-tapping variations. The screws offered are variable angle and fixed angle thus providing four (4) types of screws. The screw diameters are 4mm and 4.5mm. The screw lengths range from 10mm to 20mm. A locking mechanism consisting of a cam fixed atop the plate is used to prevent screw back out. The device is made from Medical Grade Titanium Alloy (Ti6A14V, ASTM F136).