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The Sterispine™ PS system is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct of fusion. Sterispine™ PS system is intended for posterior non-cervical, pedicle and nonpedicle fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation) ; spinal stenosis ; tumor ; pseudoarthrosis and failed previous fusion.

The cleared range of Sterispine™ PS system includes multiaxial screws and cannulated multiaxial screws with or without extended head (Ø5.5, 6.5 and 7.5mm, lengths from 25 to 85mm) and straight and prebent rods (Ø5.5, 6.5 and 7.5mm, lengths from 30 to 380mm). Sterispine™ PS implants are supplied sterile with a sterile single-use set of surgical instruments supplied in kits. Bacterial endotoxin testing as specified in USP standard is used for pyrogenicity testing to achieve the Endotoxin limit of 20 EU / device.

The Sterispine™ PS system is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct of fusion. Sterispine™ PS system is intended for posterior, non-cervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; tumor; pseudoarthrosis and failed previous fusion.

The cleared range of Sterispine™ Ps system include multiaxial screws and cannulated multiaxial screws with or without extended head (Ø5.5, 6.5 and 7.5mm, lengths from 25 to 60mm) and straight and prebent rods (Ø5.5, 6.5 and 7.5mm, lengths from 30 to 380mm). Components of Sterispine™ PS range of products is supplied sterile with a sterile single-use set of surgical instruments.

The Sterispine™M CC is intended to be used as an intervertebral body fusion cage as a standalone system used with bone screws provided and requires no additional supplementary fixation systems. It is inserted between the vertebral bodies into the disc space from levels C2 to T1 for the treatment of cervical degenerative disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The device system is designed for use with autograft bone to facilitate fusion. Sterispine™ CC is intended to be used at one level. The cervical cage is to be used in a skeletally mature patient who has had six weeks of non-operative treatment prior to implantation of the cage.

Sterispine™ CC system includes one cervical cage and four cervical fixations (two cervical fixations screws and two rescue screws) but only two screws are used within the cervical cage. Implantable components of Sterispine™ CC are made of Titanium Ta6V Eli grade conforming to ASTM F136 for screws and the cervical cage is made of VESTAKEEP i4R (PEEK) conforming to the ASTM F2026 with one Tantalum marker conforming to ASTM F560 to visualize the position of the cervical cage in the disc space. The Sterispine™ CC range of products is supplied sterile with a sterile single-use set of surgical instruments.

The SteriSpine™PS system is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion. SteriSpine™PS System is intended for posterior, non-cervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; tumor; pseudoarthrosis; and failed previous fusion.

SteriSpine™PS system includes pedicle screws (multiaxial and cannulated) and rods (straight and prebent). Implantable components of SteriSpine™PS system are made of Titanium Ti-6Al-4V ELI according to ASTM F136. The SteriSpine™PS range of products is supplied sterile with a sterile single-use set of surgical instruments.

The SteriSpine™PS system is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion. SteriSpine™PS System is intended for posterior, non-cervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; tumor; pseudoarthrosis; and failed previous fusion.

SteriSpineTMPS system includes pedicle screws (multiaxial and cannulated) and rods (straight and prebent). Implantable components of SteriSpineTMPS system are made of Titanium Ta6V Eli grade conforming to ASTM F136. The SteriSpineTMPS range of products is supplied sterile with a sterile single-use set of surgical instruments.

The SteriSpine™LC device is indicated for intervertebral body fusion procedures at one or two contiguous levels from L2 to S1 in skeletally mature patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage. This device is to be used with autogenous bone graft to facilitate fusion and is intended for use with SteriSpine™ PS, a supplemental fixation system cleared by the FDA for use in the lumbar spine.

The SteriSpine™LC cages are intervertebral body fusion devices with a central cavity available either in straight rectangular shape for transforaminal (TLIF) or posterior (PLIF) approach and in curved shape for transforaminal (TLIF) approach. The SteriSpine™LC cages are made of PEEK (Zeniva ZA-500) conforming to ASTM F2026 with Tantalum markers conforming ASTM F560 to visualize the position of the implant in the disc space. The SteriSpine™LC cages are available in several sizes to adapt to anatomical variations. The SteriSpine™LC range of products is supplied sterile with a sterile single-use set of surgical instruments.

The SteriSpine™PS system is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion. SteriSpine™PS System is intended for posterior, non-cervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; tumor; pseudoarthrosis; and failed previous fusion.

The cleared range of SteriSpineTM PS system include multiaxial screws and cannulated multiaxial screws with or without extended head (ø5.5, 6.5 and 7.5mm, lengths from 25 to 60 mm) and straight and prebent rods (ø 5.5, 6.5 and 7.5mm, lengths from 30 to 380 mm). Components of SteriSpineTM PS system are made of Titanium Ta6V Eli grade conforming to ASTM F136. The SteriSpineTM PS range of products is supplied sterile with a sterile single-use set of surgical instruments. The Percutaneous Ancillary Kit added within this submission include (trocar needle, dilators, rod measurer, protection sleeve, funnel body, funnel shaft and funnel impactor). These instruments are supplied as a sterile single-use set to be used with the previously cleared Ancillary Kits.

The SteriSpine™PS system is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion. SteriSpine™PS System is intended for posterior, non-cervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; tumor; pseudoarthrosis; and failed previous fusion.

SteriSpineTMPS system includes Pedicle Screws and Rods. Components of SteriSpineTMPS system are made of Titanium Ta6V Eli grade conforming to ASTM F136. Components added within this submission include multi-axial extended head screws and multi axial extended head cannulated screws Ø 5.5, 6.5 and 7.5 (length from 25 to 60 mm), additional lengths for straight and prebent rods ø5.5mm, additional surgical instruments (screw head breakage tip, set screw holder and racking compression pliers, Ratchet module). The SteriSpineTMPS range of products is supplied sterile with a sterile single-use set of surgical instruments.

The SteriSpine™LC device is indicated for intervertebral body fusion procedures at one or two contiguous levels from L2 to S1 in skeletally mature patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage. This device is to be used with autogenous bone graft to facilitate fusion and is intended for use with SteriSpine™ PS, a supplemental fixation system cleared by the FDA for use in the lumbar spine.

The SteriSpine™LC cages are intervertebral body fusion devices with a central cavity that is filled with bone graft (autograft) to facilitate fusion. The SteriSpine™LC is available either in straight rectangular shape for transforaminal (TLIF) or posterior (PLIF) approach and in curved shape for transforaminal (TLIF) approach. The SteriSpine™LC is made of (Zeniva ZA-500) conforming to ASTM F2026 with Tantalum markers conforming ASTM F560 to visualize the position of the implant in the disc space. The SteriSpine™LC cages are available in several sizes to adapt to anatomical variations.

The SteriSpine" PS system is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion. SteriSpine"PS System is intended for posterior, non-cervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; tumor; pseudoarthrosis; and failed previous fusion.

system includes Pedicle Screws and Rods. Components SteriSpine™PS of SteriSpine™PS system are made of Titanium Ta6V Eli grade conforming to ASTM F136. SteriSpine™PS components are supplied sterile with a single-use set of surgical instruments. Components added within this submission include multi-axial pedicle screws with extended head and associated instruments.