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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 Device Size Type Device Class Implantable

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Lumbar-P-TLIF 24Dx10Wx09Hx0°
Zsfab, Inc.
24100900
In Commercial Distribution

  • 00850035165355 ()

  • Depth: 24 Millimeter
  • Width: 10 Millimeter
  • Height: 9 Millimeter
  • Angle: 0 degree


  • Metallic spinal interbody fusion cage
Lumbar-P-TLIF 24Dx10Wx08Hx0°
Zsfab, Inc.
24100800
In Commercial Distribution

  • 00850035165348 ()

  • Depth: 24 Millimeter
  • Width: 10 Millimeter
  • Height: 8 Millimeter
  • Angle: 0 degree


  • Metallic spinal interbody fusion cage
Simplex® HV with Gentamicin is a fast-setting acrylic resin with addition of gentamicin sulfate for use in bone surgery. Mixing the two separate sterile components produces a ductile bone cement which, after hardening, fixes the implant and transfers stresses produced during movement evenly to the bone. Simplex® HV with Gentamicinn cement powder also contains insoluble zirconium dioxide as an X-ray contrast medium. Simplex® HV with Gentamicin does not emit a signal and does not pose a safety risk in a magnetic resonance environment.
OSARTIS GmbH
6195-1-001
In Commercial Distribution

  • 24260056885765 ()
  • 14260056885768 ()
  • 04260056885761 ()

  • Total Volume: 20 Milliliter
  • Weight: 40.8 Gram
6195-1-010

  • Orthopaedic cement, antimicrobial
Simplex® HV is a fast-setting acrylic resin for use in bone surgery. Mixing the two separate sterile components produces a ductile bone cement which, after hardening, fixes the implant and transfers stresses produced during movement evenly to the bone. Simplex® HV cement powder also contains insoluble zirconium dioxide as an X-ray contrast medium. Simplex® HV does not emit a signal and does not pose a safety risk in a magnetic resonance environment.
OSARTIS GmbH
6194-1-001
In Commercial Distribution

  • 24260056885741 ()
  • 14260056885744 ()
  • 04260056885747 ()

  • Total Volume: 20 Milliliter
  • Weight: 40 Gram
6194-1-010

  • Orthopaedic cement, non-antimicrobial
BonOs® R Genta is a fast-setting acrylic resin with addition of gentamicin sulfate for use in bone surgery. Mixing the two separate sterile components produces a ductile bone cement which, after hardening, fixes the implant and transfers stresses produced during movement evenly to the bone. BonOs® R Genta cement powder also contains insoluble zirconium dioxide as an X-ray contrast medium. BonOs® R Genta does not emit a signal and does not pose a safety risk in a magnetic resonance environment.
OSARTIS GmbH
01-0217
In Commercial Distribution

  • 14260056885676 ()
  • 04260056885679 ()

  • Weight: 40.8 Gram


  • Orthopaedic cement, antimicrobial
BonOs® R is a fast-setting acrylic resin for use in bone surgery. Mixing the two separate sterile components produces a ductile bone cement which, after hardening, fixes the implant and transfers stresses produced during movement evenly to the bone. BonOs® R cement powder also contains insoluble zirconium dioxide as an X-ray contrast medium. BonOs® R does not emit a signal and does not pose a safety risk in a magnetic resonance environment.
OSARTIS GmbH
01-0117
In Commercial Distribution

  • 14260056885621 ()
  • 04260056885624 ()

  • Weight: 40 Gram


  • Orthopaedic cement, non-antimicrobial
BonOs® Inject is a radiopaque, injectable bone cement for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using vertebroplasty or balloon kyphoplasty procedure. When used in conjunction with NEO Pedicle Screw System™ BonOs® Inject is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. NEO Pedicle Screws augmented with BonOs® Inject Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised. Mixing the two separate sterile components initially produces a ductile, injectable bone cement which, after hardening in situ, is able to stabilize neoplastic vertebral lesions and vertebral compression fractures. BonOs® Inject cement powder also contains insoluble zirconium dioxide as an X-ray contrast medium.
OSARTIS GmbH
01-0309
In Commercial Distribution

  • 04260056883231 ()
  • 14260056883238 ()

  • Weight: 24 Gram


  • Vertebral bone filler, non-bioabsorbable
BonOs® HV Genta is a fast-setting acrylic resin with addition of gentamicin sulfate for use in bone surgery. Mixing the two separate sterile components produces a ductile bone cement which, after hardening, fixes the implant and transfers stresses produced during movement evenly to the bone. BonOs® HV Genta cement powder also contains insoluble zirconium dioxide as an X-ray contrast medium. BonOs® HV Genta does not emit a signal and does not pose a safety risk in a magnetic resonance environment.
OSARTIS GmbH
1x40
In Commercial Distribution

  • 04260056882623 ()
  • 14260056882620 ()

  • Weight: 40.8 Gram
01-0262

  • Orthopaedic cement, antimicrobial
BonOs® HV is a fast-setting acrylic resin for use in bone surgery. Mixing the two separate sterile components produces a ductile bone cement which, after hardening, fixes the implant. BonOs® HV cement powder also contains insoluble zirconium dioxide as an X-ray contrast medium. BonOs® HV does not emit a signal and does not pose a safety risk in a magnetic resonance environment.
OSARTIS GmbH
1x40
In Commercial Distribution

  • 04260056882579 ()

  • Weight: 40 Gram
01-0162

  • Orthopaedic cement, non-antimicrobial
Vertecem II is a radio-opaque, injectable acrylic bone cement used for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a Vertebroplasty or Kyphoplasty procedure.
OSARTIS GmbH
08.702.017S
In Commercial Distribution

  • 04260056880759 ()
  • 14260056880756 ()

  • Weight: 22 Gram
08.702.017S

  • Vertebral bone filler, non-bioabsorbable
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