Address:Auf der Beune 101,Muenster Hesse,DE
Device Description : Vertecem II is a radio-opaque, injectable acrylic bone cement used for the treat 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.
Device Class :
Duns Number: 344261631
Premarket Exempt : No
Prescription Use : Yes
Device Description : ManuMix® is a mixing system for bone cements of low to medium viscosity and subs ManuMix® is a mixing system for bone cements of low to medium viscosity and subsequent transfer in syringes for clinical application.
Device Class : 1
Duns Number: 344261631
Premarket Exempt : Yes
Prescription Use : No
Device Description : BonOs® Inject is a radiopaque, injectable bone cement for use in spine surgery l BonOs® Inject is a radiopaque, injectable bone cement for use in spine surgery like percutaneous vertebral augmentation during vertebroplasty or kyphoplasty. 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.
Device Class :
Duns Number: 344261631
Premarket Exempt : No
Prescription Use : Yes
Device Description : Vacuum mixing system for mixing of PMMA bone cements
Device Class : 1
Duns Number: 344261631
Premarket Exempt : Yes
Prescription Use : No
Device Description : BonOs® R is a fast-setting acrylic resin for use in bone surgery. Mixing the two 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.
Device Class : 2
Duns Number: 344261631
Premarket Exempt : No
Prescription Use : Yes
Device Description : BonOs® R Genta is a fast-setting acrylic resin with addition of gentamicin sulfa 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.
Device Class : 2
Duns Number: 344261631
Premarket Exempt : No
Prescription Use : Yes
Device Description : Simplex® HV is a fast-setting acrylic resin for use in bone surgery. Mixing the 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.
Device Class : 2
Duns Number: 344261631
Premarket Exempt : No
Prescription Use : Yes
Device Description : Simplex® HV with Gentamicin is a fast-setting acrylic resin with addition of gen 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.
Device Class : 2
Duns Number: 344261631
Premarket Exempt : No
Prescription Use : Yes