Address:VIA ANDREA DORIA 6,VERONA Veneto,IT
Device Description : Temporary hip spacer with gentamicin. Interspace Tapered Wedge Stem is composed Temporary hip spacer with gentamicin. Interspace Tapered Wedge Stem is composed of fully formed gentamicin/polymethylmethacrylate (PMMA) radiopaque bone cement coated onto a stainless steel reinforcing structure. The device has a rectangular profile stem. Interspace Tapered Wedge Stem is sterile and single-use. InterSpace Tapered Wedge Stem is indicated for temporary use (maximum of 180 days) as a total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. The device is inserted into the femoral medullary canal and acetabular cavity following removal of the existing implant and radical debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). InterSpace Tapered Wedge Stem is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g., resection arthroplasty, fusion, etc.).
Device Class : 2
Duns Number: 435428396
Premarket Exempt : No
Prescription Use : Yes
Device Description : Temporary hip spacer with gentamicin. Interspace Tapered Wedge Stem is composed Temporary hip spacer with gentamicin. Interspace Tapered Wedge Stem is composed of fully formed gentamicin/polymethylmethacrylate (PMMA) radiopaque bone cement coated onto a stainless steel reinforcing structure. The device has a rectangular profile stem. Interspace Tapered Wedge Stem is sterile and single-use. InterSpace Tapered Wedge Stem is indicated for temporary use (maximum of 180 days) as a total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. The device is inserted into the femoral medullary canal and acetabular cavity following removal of the existing implant and radical debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). InterSpace Tapered Wedge Stem is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g., resection arthroplasty, fusion, etc.).
Device Class : 2
Duns Number: 435428396
Premarket Exempt : No
Prescription Use : Yes
Device Description : Temporary hip spacer with gentamicin. Interspace Tapered Wedge Stem is composed Temporary hip spacer with gentamicin. Interspace Tapered Wedge Stem is composed of fully formed gentamicin/polymethylmethacrylate (PMMA) radiopaque bone cement coated onto a stainless steel reinforcing structure. The device has a rectangular profile stem. Interspace Tapered Wedge Stem is sterile and single-use. InterSpace Tapered Wedge Stem is indicated for temporary use (maximum of 180 days) as a total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. The device is inserted into the femoral medullary canal and acetabular cavity following removal of the existing implant and radical debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). InterSpace Tapered Wedge Stem is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g., resection arthroplasty, fusion, etc.).
Device Class : 2
Duns Number: 435428396
Premarket Exempt : No
Prescription Use : Yes
Device Description : Temporary hip spacer with gentamicin. Interspace Tapered Wedge Stem is composed Temporary hip spacer with gentamicin. Interspace Tapered Wedge Stem is composed of fully formed gentamicin/polymethylmethacrylate (PMMA) radiopaque bone cement coated onto a stainless steel reinforcing structure. The device has a rectangular profile stem. Interspace Tapered Wedge Stem is sterile and single-use. InterSpace Tapered Wedge Stem is indicated for temporary use (maximum of 180 days) as a total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. The device is inserted into the femoral medullary canal and acetabular cavity following removal of the existing implant and radical debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). InterSpace Tapered Wedge Stem is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g., resection arthroplasty, fusion, etc.).
Device Class : 2
Duns Number: 435428396
Premarket Exempt : No
Prescription Use : Yes
Device Description : Freezer ring is an accessory intended to be applied to the syringe of Mendec Spi Freezer ring is an accessory intended to be applied to the syringe of Mendec Spine Kit. It allows a longer extrusion time of the resin.
Device Class : 1
Duns Number: 435428396
Premarket Exempt : Yes
Prescription Use : No
Device Description : InterSpace Shoulder Trial is intended to be used for the selection of the right InterSpace Shoulder Trial is intended to be used for the selection of the right size of InterSpace Shoulder to be implanted.
Device Class : 1
Duns Number: 435428396
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : Conflow Bone Cement is a low viscosity polymethylmethacrylate bone cement. It is Conflow Bone Cement is a low viscosity polymethylmethacrylate bone cement. It is composed by two components (40g powder and 13,3g liquid) which are designed for mixing together at the point of use to form the cement. The device is supplied sterile, for single use. Conflow Bone Cement is indicated for the fixation of joint prosthesis implants to the host bone.
Device Class : 2
Duns Number: 435428396
Premarket Exempt : No
Prescription Use : Yes
Device Description : Conflow G Bone Cement is a low viscosity antibiotic-loaded polymethylmethacrylat Conflow G Bone Cement is a low viscosity antibiotic-loaded polymethylmethacrylate bone cements. It is composed by two components (40g powder and 14,7g liquid) which are designed for mixing together at the point of use to form the cement. The device is supplied sterile, for single use. Conflow G Bone Cement is indicated for the fixation of prostheses to living bone in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.
Device Class : 2
Duns Number: 435428396
Premarket Exempt : No
Prescription Use : Yes
Device Description : MectaCem-X LV is a low viscosity polymethylmethacrylate bone cement. It is compo MectaCem-X LV is a low viscosity polymethylmethacrylate bone cement. It is composed by two components (40g powder and 13,3g liquid) which are designed for mixing together at the point of use to form the cement. The device is supplied sterile, for single use. MectaCem-X LV is indicated for the fixation of joint prosthesis implants to the host bone.
Device Class : 2
Duns Number: 435428396
Premarket Exempt : No
Prescription Use : Yes
Device Description : MectaCem-X HV is a low viscosity polymethylmethacrylate bone cement. It is compo MectaCem-X HV is a low viscosity polymethylmethacrylate bone cement. It is composed by two components (40g powder and 13,3g liquid) which are designed for mixing together at the point of use to form the cement. The device is supplied sterile, for single use. MectaCem-X HV is indicated for the fixation of joint prosthesis implants to the host bone.
Device Class : 2
Duns Number: 435428396
Premarket Exempt : No
Prescription Use : Yes