Address:VIA ANDREA DORIA 6,VERONA Veneto,IT
Device Description : Bowl and Spatula are accessories intended for bone cement mixing.
Device Class : 1
Duns Number: 435428396
Premarket Exempt : Yes
Prescription Use : No
Device Description : Cement Restrictor designed to be inserted into the femoral medullary canal to li Cement Restrictor designed to be inserted into the femoral medullary canal to limit the flow of bone cement and to aid the cement pressurization during primary or revision hip arthroplasty surgery. It is a single-use and permanent, implantable, sterile device. Cement Restrictor is provided with the related inserter.
Device Class : 2
Duns Number: 435428396
Premarket Exempt : No
Prescription Use : Yes
Device Description : Cement Restrictor designed to be inserted into the femoral medullary canal to li Cement Restrictor designed to be inserted into the femoral medullary canal to limit the flow of bone cement and to aid the cement pressurization during primary or revision hip arthroplasty surgery. It is a single-use and permanent, implantable, sterile device.Cement Restrictor is provided with the related inserter.
Device Class : 2
Duns Number: 435428396
Premarket Exempt : No
Prescription Use : Yes
Device Description : The device is an accessory intended to fill up to six needles or fillers with ac The device is an accessory intended to fill up to six needles or fillers with acrylic resins for vertebroplasty/kyphoplasty at the same time.
Device Class : 1
Duns Number: 435428396
Premarket Exempt : Yes
Prescription Use : No
Device Description : BONE INJECTION NEEDLE beveled tip 11 Gauge 120 mm length with plastic handgrip i BONE INJECTION NEEDLE beveled tip 11 Gauge 120 mm length with plastic handgrip intended for the injection of acrylic resin.
Device Class : 1
Duns Number: 435428396
Premarket Exempt : Yes
Prescription Use : No
Device Description : BONE INJECTION NEEDLE beveled tip 13 Gauge 120 mm length with metal handgrip int BONE INJECTION NEEDLE beveled tip 13 Gauge 120 mm length with metal handgrip intended for the injection of acrylic resin.
Device Class : 1
Duns Number: 435428396
Premarket Exempt : Yes
Prescription Use : No
Device Description : Cement Restrictor designed to be inserted into the femoral medullary canal to li Cement Restrictor designed to be inserted into the femoral medullary canal to limit the flow of bone cement and to aid the cement pressurization during primary or revision hip arthroplasty surgery. It is a single-use and permanent, implantable, sterile device.
Device Class : 2
Duns Number: 435428396
Premarket Exempt : No
Prescription Use : Yes
Device Description : Cement Restrictor designed to be inserted into the femoral medullary canal to li Cement Restrictor designed to be inserted into the femoral medullary canal to limit the flow of bone cement and to aid the cement pressurization during primary or revision hip arthroplasty surgery. It is a single-use and permanent, implantable, sterile device.
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