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The PLIF Lite and TLIF Lite Lumbar Interbody Fusion Devices are indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The PLIF Lite and TLIF Lite Lumbar Interbody Fusion Devices are designed for use with autograft bone to facilitate fusion and are intended for use with supplemental fixation systems cleared for use in the lumbar spine.

The PLIF Lite and TLIF Lite Lumbar Interbody Fusion Devices are made from PEEK. The PLIF Lite implants are available in lordotic and non-lordotic form, while the TLIF implants are provided with 7 degrees of lordosis only. The implants are available in various heights and lengths to accommodate patients' anatomy. The implants are provided sterile, and a set of instrument for implantation is provided to facilitate implantation. Three radiographic markers made of titanium alloy (ASTM F-136) are included in each implant to allow radiographic visualization.

The Spider System Kolibri Cement Needle is intended to be used as a system for the creation of a cavity in cancellous bone in the spine, in order to treat pathological compression fractures that may result from osteoporosis, benign lesions, and/or malignant lesions. This system is to be used with an already FDA cleared PMMA bone cement.

The needle has the following characteristics: - . entirely cannulated needle; - threaded proximal end to screw the needle into the pedicle to temporarily link the . needle to the pedicle during the cement injection; . - . luer-lock to allow the easy connection with standard syringes and with other system of injection of the cement; - . windows in the distal end that allow the outflow of cement and its optimal distribution around the needle. The device is supplied in an appropriately labeled sterile packaging.

The Sintea Plustek Anterior Cervical Plate systems in indicated for use in the cervical spine (C3-C7) for the following conditions: - Degenerative Disc Disease (defined as neck pain of discogenic origin with . degeneration of the disc confirmed by history and radiographic studies) - . Spondylolisthesis - . Trauma (fracture or dislocation) - . Spinal stenosis - Deformities or curvatures (scoliosis, kyphosis, lordosis) ● - . Tumor - . Pseudarthrosis - . Failed previous fusion

The Sintea Plustek Anterior Cervical Plate system is made of medical grade titanium alloy Ti-6Al-4V according to ASTM-F136 and consists of plate and screws of various lengths to accommodate single or multilevel fusion and various patients' anatomy. All of the plates have 2.5mm thickness. One level plates are available from 18-38mm, two level plates from 34-56mm, three level plates from 68-112mm and 4 level plates from The screws are available in three configurations: 4mm diameter self 103-128mm. tapping screws in lengths of 10, 12, 14, 16 and 18mm. 4.5 diameter self tapping screws in lengths of 10, 12, 14, 16, and 18mm, 4mm diameter self drilling screws in lengths of 10, 12, 14, 16 and 18mm. The plates have an anti-backout feature based on an elastic ring The elastic ring is inserted into a (made titanium alloy Ti-6AI-4V as well). circumferential slot in the holes present on the plates. The ring can be deformed by the screw during the insertion in order to allow the screw to fit the hole of the plate. Once the screw it is completely inserted the ring return elastically to its original shape in order to prevent screw backout.