Address:PHILIPP-REIS-STRASSE 8/13,WEHRHEIM Hesse,DE
Device Description : COPAL® exchange G Trials are an accessory device for intra-operative determinati COPAL® exchange G Trials are an accessory device for intra-operative determination of the correct size of the COPAL® exchange G Spacer. COPAL® exchange G Trials are used for a very short period of time (few minutes) during the first stage of a two-stage exchange septic revision surgery after thorough debridement and are intended for single use. COPAL® exchange G hip and knee Trials resemble the COPAL® exchange G hip and knee Spacers in size, shape and geometry. COPAL® exchange G Trials are easily distin-guishable from COPAL® exchange G Spacers due to their hollow body, their prominent blue color and the stamping “TRIAL - DO NOT IMPLANT”.COPAL® exchange G Trials are available for hip and knee. COPAL® exchange G hip Trials resemble a hemi-endopros-thesis and are available in 8 different sizes. COPAL® exchange G knee Trials consist of a femoral and tibial component and are available in 3 different sizes.COPAL® exchange G Trials do not contain gentamicin.
Device Class :
Duns Number: 333623937
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : Nozzle to be used in combination with PALACOS Pro system
Device Class : 1
Duns Number: 333623937
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The Pro Nozzle short with knee pressurizer is used in combination with the Pro b The Pro Nozzle short with knee pressurizer is used in combination with the Pro bone cement system
Device Class : 1
Duns Number: 333623937
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : PALAMIX® is a vacuum mixing and application system for bone cements. It consists PALAMIX® is a vacuum mixing and application system for bone cements. It consists of: –PALAMIX® uno or PALAMIX® duo vacuum mixing systemPALAMIX® uno and PALAMIX® duo allow for automatic collection of bone cement within the mixing cartridge under vacuum.
Device Class :
Duns Number: 333623937
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : PALAMIX® is a vacuum mixing and application system for bone cements. It consists PALAMIX® is a vacuum mixing and application system for bone cements. It consists of: –PALAMIX® uno or PALAMIX® duo vacuum mixing systemPALAMIX® uno and PALAMIX® duo allow for automatic collection of bone cement within the mixing cartridge under vacuum.
Device Class :
Duns Number: 333623937
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The PALACOS® MV pro system consists of a mixing and application system prefilled The PALACOS® MV pro system consists of a mixing and application system prefilled with PALACOS® polymer powder and monomer liquid. PALACOS® MV pro is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.
Device Class :
Duns Number: 333623937
Premarket Exempt : No
Prescription Use : Yes
Device Description : The PALACOS® MV pro system consists of a mixing and application system prefilled The PALACOS® MV pro system consists of a mixing and application system prefilled with PALACOS® polymer powder and monomer liquid. PALACOS® MV pro is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.
Device Class :
Duns Number: 333623937
Premarket Exempt : No
Prescription Use : Yes
Device Description : PALACOS® R is a fast-curing, radiopaque, poly(methyl methacrylate)-based bone ce PALACOS® R is a fast-curing, radiopaque, poly(methyl methacrylate)-based bone cement.PALACOS ® R contains the X-ray contrast medium zirconium dioxide. To improve visibility in the surgical field PALACOS ® R has been coloured with chlorophyll (E141). The bone cement is prepared directly before use by mixing a polymer powder component with a liquid monomer component. A ductile dough forms which cures within a few minutes.
Device Class :
Duns Number: 333623937
Premarket Exempt : No
Prescription Use : Yes
Device Description : PALACOS® R+G is a fast setting polymer containing gentamicin, for use in bone su PALACOS® R+G is a fast setting polymer containing gentamicin, for use in bone surgery. Mixing of the two component system, consisting of a powder and a liquid, initially produces a liquid and then a paste, which is used to anchor the prosthesis to the bone. The hardened bone cement allows stable fixation of the prosthesis and Transfers all stresses produced in a movement to the bone via the large interface. Insoluble zirconium dioxide is included in the cement powder as an X ray contrast medium. The chlorophyll additive serves as optical marking of the bone cement at the site of the operation.
Device Class :
Duns Number: 333623937
Premarket Exempt : No
Prescription Use : Yes
Device Description : PALACOS® LV is a slow-curing, radiopaque, poly(methyl methacrylate)-based bone c PALACOS® LV is a slow-curing, radiopaque, poly(methyl methacrylate)-based bone cement.PALACOS® LV contains the X-ray contrast medium zirconium dioxide. To improve visibility in the surgical field it has been coloured with chlorophyll (E141).The bone cement is prepared directly before use by mixing a polymer powder component with a liquid monomer component. A ductile dough forms which cures within a few minutes.
Device Class :
Duns Number: 333623937
Premarket Exempt : No
Prescription Use : Yes