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Devine Spinal System is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization and immobilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: (1) trauma (i.e. fracture or dislocation), (2) curvatures (scoliosis, kyphosis, and/or lordosis), (3) spinal tumor, (4) failed previous fusion (5) pseudarthrosis, (6) spinal stenosis. It is not intended for pedicle screw fixation above TS.

The proposed devices of Devine Spinal System is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization and immobilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: (1) trauma (i.e. fracture or dislocation), (2) curvatures (scoliosis, kyphosis, and/or lordosis), (3) spinal tumor, (4) failed previous fusion (5) pseudarthrosis, (6) spinal stenosis. It is made of Titanium Alloy (Ti-6AL-4V), which meet ASTM F136-02a, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surgical implants with well known biocompatibility. The proposed device includes three models, which are TL5.5, TL6.0 and TL6.35. All models use the same material, and same design principle. The only difference is the parts size which does not affect the design. There is no surface modified or coated. The proposed device consists of the following components: FAS, Reduction FAS, Spine Hook, Rod and Crosslink Plate The proposed devices are not provided sterile. It is required to be sterilized via autoclave method to reach a SAL of 100 by the hospital prior to surgery. The sterilization method is presented in the user manual, which was validated per 150 17665-1: 2006 Sterilization of health care products -- Moist heat - Part 1: Requirements for the development, validation, and routine control of a sterilization. process for medical devices.