Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds
Osartis GmbH
OSARTIS GMBH
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 9615014 | 3005568854 | OSARTIS GMBH | 1 | N | 2026-01-01 | Auf der Beune 101 Muenster Hesse DE 64839 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 208324 | 1333163189 | K210125 | BonOs HV Genta, BonOs MV Genta, BonOs LV Genta | LOD | 2021-03-19 |
| 208324 | 1594185745 | K210120 | BonOs HV, BonOs MV, BonOs LV | LOD | 2021-03-19 |
| 208324 | 1475622988 | K203835 | MIS Solution | FRO | 2021-04-23 |
| 208324 | 1970989215 | K202458 | BonOs Inject, Pedicle screw kits, Cement pusher | LOD | 2021-05-18 |
| 208324 | 1789024609 | K163188 | Next Science Wound Gel (Rx) | FRO | 2017-03-06 |
| 208324 | 1652824773 | K123225 | BONOS R 1X20, BONOS R 2X20, BONOS R 1X40, BONOS R 2X40, BONOS R 1X60 | LOD | 2013-03-15 |
| 208324 | 1663684538 | K123081 | BONOS R GENTA 1X20 MODEL 01-0228; BONOS R GENTA 2X20 MODEL 01-0229; BONOS R GENTA 1X40 MODEL 01-0217; BONOS R GENTA 2X40 | LOD | 2013-03-07 |
| 208324 | 1232604137 | K121876 | VERTECEM II CEMENT KIT | NDN | 2012-10-19 |
| 208324 | 1523610949 | K092150 | COBALT MV WITH GENTAMICIN (AKA COBALT G-MV) BONE CEMENT | LOD | 2009-10-27 |
| 208324 | 1772643145 | K091608 | COBALT MV BONE CEMENT | LOD | 2009-09-17 |
| 208324 | 1452199745 | K090460 | BONOS INJECT | NDN | 2009-04-14 |
| 208324 | 1240504171 | ||||
| 208324 | 1365492995 | ||||
| 208324 | 1406688845 | ||||
| 208324 | 1412010583 | ||||
| 208324 | 1512260026 | ||||
| 208324 | 1667564800 | ||||
| 208324 | 1936699338 | ||||
| 208324 | 2002387796 |
Product Codes Associated With Registrations#
PMN#
BonOs Inject, Pedicle screw kits, Cement pusher
Osartis GmbH
BonOs HV Genta, BonOs MV Genta, BonOs LV Genta
OSARTIS GmbH
BonOs HV, BonOs MV, BonOs LV
Osartis GmbH
Hi-Fatigue Bone Cement
OSARTIS GmbH
Hi-Fatigue G Bone Cement
OSARTIS GmbH
GUDID#
XPERIENCE Advanced Surgical Irrigation - XPERIENCE Advanced Surgical Irrigation is a clear, colorless solution indicated for cleansing and removal of debris, including microorganisms, from wounds.
2026-04-01
BLASTX® - BLASTX® Next Science Wound Gel is a hydrogel that helps to maintain a moist wound environment that is conducive to healing.It is indicated for the management of wounds such as Stage I-IV pressure ulcers, partial and full thickness wounds, diabetic foot and leg ulcers, post-surgical wounds, first and second degree burns, grafted and donor sites.
2026-02-19
BLASTX® - BLASTX® Next Science Wound Gel is a hydrogel that helps to maintain a moist wound environment that is conducive to healing. It is indicated for the management of wounds such as Stage I-IV pressure ulcers, partial and full thickness wounds, diabetic foot and leg ulcers, post-surgical wounds, first and second degree burns, grafted and donor sites.
2026-02-19
BonOs HV - 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.
2024-05-17
BonOs HV Genta - 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.
2024-04-03
Vertecem II Cement Kit - 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.
2015-10-21
BonOs Inject - 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.
2015-10-02
EASYMIX® Nozzle slim - The vacuum mixing systems EASYMIX® is a mixing systems for PMMA bone cements, which are indicated to be used with a mixing system. The mixing system is composed of the mixing cartridge with the socket, the mixing paddle with the handle, the funnel, the femoral pressurizer, the tubing to the vacuum pump and the standard nozzle.The EASYMIX® Nozzle slim is shorter and of smaller diameter than the standard nozzle provided with the EASYMIX® vacuum mixing system.
2022-12-01
EASYMIX® Nozzle revision - The vacuum mixing systems EASYMIX® is a mixing systems for PMMA bone cements, which are indicated to be used with a mixing system. The mixing system is composed of the mixing cartridge with the socket, the mixing paddle with the handle, the funnel, the femoral pressurizer, the tubing to the vacuum pump and the standard nozzle.The EASYMIX® Nozzle revision is longer and of larger diameter than the EASYMIX® standard nozzle.
2022-12-01
EASYMIX® Nozzle slim - The vacuum mixing systems EASYMIX® is a mixing systems for PMMA bone cements, which are indicated to be used with a mixing system. The mixing system is composed of the mixing cartridge with the socket, the mixing paddle with the handle, the funnel, the femoral pressurizer, the tubing to the vacuum pump and the standard nozzle. The EASYMIX® Nozzle slim is shorter and of smaller diameter than the standard nozzle provided with the EASYMIX® vacuum mixing system.
2022-12-01
EASYMIX® Nozzle revision - The vacuum mixing systems EASYMIX® is a mixing systems for PMMA bone cements, which are indicated to be used with a mixing system. The mixing system is composed of the mixing cartridge with the socket, the mixing paddle with the handle, the funnel, the femoral pressurizer, the tubing to the vacuum pump and the standard nozzle. The EASYMIX® Nozzle revision is longer and of larger diameter than the EASYMIX® standard nozzle.
2022-12-01
EASYMIX® compressed air hose - EASYMIX® compressed air hose, 5 m, Medap wall coupling.The compressed air hoses connect the EASYMIX® vacuum pump to the compressed air supply of the hospital.
2022-12-01
EASYMIX® compressed air hose - EASYMIX® compressed air hose, 5 m, DIN 13260-2 wall coupling.Compressed air hoses connect the EASYMIX® vacuum pump to the compressed air supply of the hospital.
2022-12-01
EASYMIX® vacuum pump I - The devices are used with an EASYMIX® vacuum mixing system to reduce air entrapment in bone cement. The pump is operated with compressed air and generates a vacuum in the connected mixing system. It is a non-sterile, re-usable device to be placed in the non-sterile area on the floor of the operating room.
2022-12-01
EASYMIX® vacuum pump II - The devices are used with an EASYMIX® vacuum mixing system to reduce air entrapment in bone cement. The pump is operated with compressed air and generates a vacuum in the connected mixing system. It is a non-sterile, re-usable device to be placed in the non-sterile area on the floor of the operating room. The EASYMIX® II vacuum pump is equipped with an indicator for functionality.
2022-12-01
EASYMIX cement injector - The cement injector is used to apply bone cements. It is operated manually and provides a secure environment for the cartridge and a constant discharge of bone cement during application. It is made of high-grade stainless steel and designed for reuse and resterilisation.The EASYMIX® cement injector is intended to be used with the EASYMIX® mixing system to apply PMMA bone cements.
2022-11-28
EASYMIX pro - Vacuum mixing system for mixing of PMMA bone cements
2021-11-11
EASYMIX pro - Vacuum mixing system for mixing of PMMA bone cements
2021-11-11
ManuMix - ManuMix® is a mixing system for bone cements of low to medium viscosity and subsequent transfer in syringes for clinical application.
2021-10-12
ManuMix - ManuMix® is a mixing system for bone cements of low to medium viscosity and subsequent transfer in syringes for clinical application.
2021-10-12
BonOs R 1x40 - 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.
2015-09-25
BonOs R Genta 1x40 - 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.
2015-09-25
Simplex HV - 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.
2015-09-24
Simplex HV with Gentamicin - 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.
2015-09-24
BonOs R 1x40 - 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.
2015-09-25
BonOs R Genta 1x40 - 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.
2015-09-25
Simplex HV - 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.
2015-09-24
Simplex HV with Gentamicin - 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.
2015-09-24