TECRES SPA

Address:VIA ANDREA DORIA 6,VERONA Veneto,IT

Want to know more about this Organization? Request more information now!


Filters
Device Class
Product Code
Premarket Exempt
Clear

Device Description : Cemex System Fast 40g is a polymethylmethacrylate bone cement with a fast settin Cemex System Fast 40g is a polymethylmethacrylate bone cement with a fast setting. Cemex System Fast 40g holds the powder (40g) and liquid (16,7g) components separately within a closed syringe-like device that serves as both a mixing chamber and a cement delivery system.The device is supplied sterile, for single use.Cemex System Fast 40g is indicated for the fixation of joint prosthesis implants to the host bone.

Device Class : 2

Duns Number: 435428396

Premarket Exempt : No

Product Code : LOD

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : Shakit is intended for mixing acrylic resins or bone void fillers components.

Device Class : 1

Duns Number: 435428396

Premarket Exempt : Yes

Product Code : JDZ

Prescription Use : No

Device Count : 1

- Catalog Number :

Device Description : XTRUDER is intended for extrusion of acrylic resins or bone void fillers prepare XTRUDER is intended for extrusion of acrylic resins or bone void fillers prepared with Tecres SHAKIT.

Device Class : 1

Duns Number: 435428396

Premarket Exempt : Yes

Product Code : KIH

Prescription Use : No

Device Count : 1

Device Description : MENDEC AQUA is a sterile single-use device for extrusion into the bone of acryli MENDEC AQUA is a sterile single-use device for extrusion into the bone of acrylic resins or bone void fillers (not supplied with the kit) intended for vertebral augmentation procedures (vertebroplasty, kyphoplasty, screw-augmentation).

Device Class : 1

Duns Number: 435428396

Premarket Exempt : Yes

Product Code : OAR

Prescription Use : No

Device Count : 1

Device Description : Temporary Augmented Tibial Stem Spacer with gentamicin. Interspace Knee ATS is c Temporary Augmented Tibial Stem Spacer with gentamicin. Interspace Knee ATS is composed of fully formed gentamicin/polymethylmethacrylate (PMMA), radio-opaque bone cement. The device is sterile and single-use.InterSpace Knee ATS is indicated for temporary use (maximum 180 days) as an adjunct to total knee replacement (TKR) in skeletally mature patients undergoing a two-stage procedure due to a septic process, and where a large tibial defect is present.InterSpace Knee ATS is applied on the tibial plate following removal of the existing implant and radical debridement. The device must be combined with the tibial component of InterSpace Knee. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).InterSpace Knee ATS 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.). Because of the inherent mechanical limitations of the device material (gentamicin/ polymethylmethacrylate), the Interspace Knee ATS is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers, canes) throughout the implantation period.

Device Class : 2

Duns Number: 435428396

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

Device Description : Temporary Augmented Tibial Stem Spacer with gentamicin. Interspace Knee ATS is c Temporary Augmented Tibial Stem Spacer with gentamicin. Interspace Knee ATS is composed of fully formed gentamicin/polymethylmethacrylate (PMMA), radio-opaque bone cement.The device is sterile and single-use.InterSpace Knee ATS is indicated for temporary use (maximum 180 days) as an adjunct to total knee replacement (TKR) in skeletally mature patients undergoing a two-stage procedure due to a septic process, and where a large tibial defect is present.InterSpace Knee ATS is applied on the tibial plate following removal of the existing implant and radical debridement. The device must be combined with the tibial component of InterSpace Knee. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).InterSpace Knee ATS 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.). Because of the inherent mechanical limitations of the device material (gentamicin/ polymethylmethacrylate), the Interspace Knee ATS is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers, canes) throughout the implantation period.

Device Class : 2

Duns Number: 435428396

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

Device Description : Temporary Augmented Tibial Stem Spacer with gentamicin. Interspace Knee ATS is c Temporary Augmented Tibial Stem Spacer with gentamicin. Interspace Knee ATS is composed of fully formed gentamicin/polymethylmethacrylate (PMMA), radio-opaque bone cement. The device is sterile and single-use.InterSpace Knee ATS is indicated for temporary use (maximum 180 days) as an adjunct to total knee replacement (TKR) in skeletally mature patients undergoing a two-stage procedure due to a septic process, and where a large tibial defect is present.InterSpace Knee ATS is applied on the tibial plate following removal of the existing implant and radical debridement. The device must be combined with the tibial component of InterSpace Knee. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).InterSpace Knee ATS 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.). Because of the inherent mechanical limitations of the device material (gentamicin/ polymethylmethacrylate), the Interspace Knee ATS is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers, canes) throughout the implantation period.

Device Class : 2

Duns Number: 435428396

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

Device Description : Temporary Augmented Tibial Stem Spacer with gentamicin. Interspace Knee ATS is c Temporary Augmented Tibial Stem Spacer with gentamicin. Interspace Knee ATS is composed of fully formed gentamicin/polymethylmethacrylate (PMMA), radio-opaque bone cement. The device is sterile and single-use.InterSpace Knee ATS is indicated for temporary use (maximum 180 days) as an adjunct to total knee replacement (TKR) in skeletally mature patients undergoing a two-stage procedure due to a septic process, and where a large tibial defect is present.InterSpace Knee ATS is applied on the tibial plate following removal of the existing implant and radical debridement. The device must be combined with the tibial component of InterSpace Knee. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).InterSpace Knee ATS 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.). Because of the inherent mechanical limitations of the device material (gentamicin/ polymethylmethacrylate), the Interspace Knee ATS is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers, canes) throughout the implantation period.

Device Class : 2

Duns Number: 435428396

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

Device Description : Mendec Aqua Cartridge is intended to be used with Mendec Aqua in vertebral augme Mendec Aqua Cartridge is intended to be used with Mendec Aqua in vertebral augmentation procedure (vertebroplasty, kyphoplasty and screw-augmentation) when the acrylic resin/bone void filler loaded in a single cartridge is not sufficient to complete the surgical procedure.

Device Class : 1

Duns Number: 435428396

Premarket Exempt : Yes

Product Code : OAR

Prescription Use : No

Device Count : 1