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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Type Device Class Implantable

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The CONKLUSION Pedicle Screw System is a spinal system that consists of a variety of hooks, screws, rods, connectors, and associated instruments. Fixation is provided by bone (pedicular) screws inserted into the vertebral body of the spine using posterior approach.
SIGNUS Medizintechnik GmbH
Rod, straight
In Commercial Distribution

  • 04047844006665 ()

  • Ø6,0x45mm
120045

  • Bone-screw internal spinal fixation system rod
The CONKLUSION Pedicle Screw System is a spinal system that consists of a variety of hooks, screws, rods, connectors, and associated instruments. Fixation is provided by bone (pedicular) screws inserted into the vertebral body of the spine using posterior approach.
SIGNUS Medizintechnik GmbH
Rod, straight
In Commercial Distribution

  • 04047844006641 ()

  • Ø6,0x35mm
120035

  • Bone-screw internal spinal fixation system rod
The CONKLUSION Pedicle Screw System is a spinal system that consists of a variety of hooks, screws, rods, connectors, and associated instruments. Fixation is provided by bone (pedicular) screws inserted into the vertebral body of the spine using posterior approach.
SIGNUS Medizintechnik GmbH
Pedicle screw
In Commercial Distribution

  • 04047844006566 ()

  • Ø7,5x70mm
101770

  • Spinal bone screw, non-bioabsorbable
The CONKLUSION Pedicle Screw System is a spinal system that consists of a variety of hooks, screws, rods, connectors, and associated instruments. Fixation is provided by bone (pedicular) screws inserted into the vertebral body of the spine using posterior approach.
SIGNUS Medizintechnik GmbH
Pedicle screw
In Commercial Distribution

  • 04047844006542 ()

  • Ø7,5x60mm
101760

  • Spinal bone screw, non-bioabsorbable
The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle screws sizes, couplers, a set screw, cross links, a washer, rods and hooks. All implantable components are manufactured from medical grade titanium alloy (Ti-6AL-4V-Eli).
SIGNUS Medizintechnik GmbH
Pedicle screw, cannulated, polyaxial
In Commercial Distribution

  • 04047844006030 ()

  • Ø4.5x40mm
MP0220-4540

  • Spinal bone screw, non-bioabsorbable
The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle screws sizes, couplers, a set screw, cross links, a washer, rods and hooks. All implantable components are manufactured from medical grade titanium alloy (Ti-6AL-4V-Eli).
SIGNUS Medizintechnik GmbH
Pedicle screw, cannulated, polyaxial
In Commercial Distribution

  • 04047844006016 ()

  • Ø4.5x30mm
MP0220-4530

  • Spinal bone screw, non-bioabsorbable
KAINOS+ is a microporous and macroporous biphasic calcium phosphate ceramic consisting of 60% Hydroxyapatite (HA) and 40% beta-Tricalcium Phosphate (ß-TCP). KAINOS+ is available in various shapes and sizes. KAINOS+ may be used with physiolo-gical saline, patient’s own serum, whole blood, or bone marrow aspirate (BMA).
SIGNUS Medizintechnik GmbH
Bone graft substitute, granules 1-2mm
In Commercial Distribution

  • 04047844006009 ()

  • 1x5cm³
KS06NT

  • Bone matrix implant, synthetic, non-antimicrobial
KAINOS+ is a microporous and macroporous biphasic calcium phosphate ceramic consisting of 60% Hydroxyapatite (HA) and 40% beta-Tricalcium Phosphate (ß-TCP). KAINOS+ is available in various shapes and sizes. KAINOS+ may be used with physiolo-gical saline, patient’s own serum, whole blood, or bone marrow aspirate (BMA).
SIGNUS Medizintechnik GmbH
Bone graft substitute, granules 1-2mm
In Commercial Distribution

  • 04047844005996 ()

  • 2x5cm³
KS03NT

  • Bone matrix implant, synthetic, non-antimicrobial
The TOSCA Anterior Cervical Plate System consits of various sizes of bone plates and screws that are either fixed angle or variable angle. The screws are used to secure the plates to the vertebral bodies of the cervical spine through the anterior approach. The plates and screws are made from Titanium alloy Ti6Al4V, are in conformance with ASTM F136, and are supplied non-sterile.
SIGNUS Medizintechnik GmbH
Connection screw
In Commercial Distribution

  • 04047844005965 ()

  • Ø3x9mm
ATM309T

  • Spinal fixation plate, non-bioabsorbable
The KIMBA®, KIMBA® mini, MOBIS® and NOVAL™ implants have a hollow, slightly curved frame with tapered edges. The frame is made from PEEK-OPTIMA®. SEMIAL® spinal implants have a semi-cylindrical form and are hollow. The implant is made from PEEK-OPTIMA®. The provision of varying heights, together with a wedge shaped option, allow better lordosis control. The TETRIS® implants (PEEK and Titanium) are hollow having a rectangular frame with lateral fenestrations. The upper and lower aspects of the implant are open and the walls feature spikes which assist in the positive anchorage and seating of the implant between the superior and inferior vertebral bodies. These implants are available in a variety of dimensional and angular sizes. This enables the surgeon to choose the size suited to the individual pathology and anatomy and condition. The MOBIS, NOVAL, SEMIAL and PEEK TETRIS devices are manufactured from polyetheretherketone (PEEK-OPTIMA® LT1, Invibio™) as described by ASTM F2026. Integral marker pins are manufactured from titanium alloy (Ti-6Al-4V) as described by ASTM F136 / ISO 5832-3 or tantalum as described by ASTM F560. The Titanium TETRIS devices are manufactured from titanium alloy (Ti-6Al-4V) as described by ASTM F136 / ISO 5832-3. The KIMBA® and KIMBA® mini devices are manufactured from ECF PEEK OPTIMA (Invibio™).
SIGNUS Medizintechnik GmbH
Lumbar cage
In Commercial Distribution

  • 04047844005842 ()

  • 13x12x32mm
MC131232

  • Polymeric spinal interbody fusion cage
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