Address:KEELE SCIENCE PARK,Keele Staffordshire,GB
Device Description : The Biosteon® ACL screw is a cannulated single-use bone screw made of a resorbab The Biosteon® ACL screw is a cannulated single-use bone screw made of a resorbable Poly (L-latic) Acid and calcium phosphate which will be gradually resorbed into the body. This function however, is patient dependent.
Device Class : 2
Duns Number: 424382307
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Biosteon® ACL Screw is a cannulated single-use bone screw made of a resorbab The Biosteon® ACL Screw is a cannulated single-use bone screw made of a resorbable Poly (l-lactic) Acid and Calcium Phosphate, which will be gradually resorbed into the body, this function however, is patient dependant.
Device Class : 2
Duns Number: 424382307
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Biosteon® ACL Screw is a cannulated single-use bone screw made of a resorbab The Biosteon® ACL Screw is a cannulated single-use bone screw made of a resorbable Poly (l-lactic) Acid and Calcium Phosphate, which will be gradually resorbed into the body, this function however, is patient dependant.
Device Class : 2
Duns Number: 424382307
Premarket Exempt : No
Prescription Use : Yes
Device Description : The STIMULAN® Bullet Mat and Introducer is a surgical instrument whcih includes The STIMULAN® Bullet Mat and Introducer is a surgical instrument whcih includes a mat for preparation of the STIMULAN® bullets, a 7mm introducer, a 9mm introducer and an obturator for hard to reach defects. To be used with 20cc Stimulan Rapid Cure
Device Class : 1
Duns Number: 424382307
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : Genex® Bone Graft Substitute is a simple to use synthetic resorbable material de Genex® Bone Graft Substitute is a simple to use synthetic resorbable material designed to promote regeneration of bone in osseous defects. It degrades into component elements normally found in the body and is highly biocompatible.The kit contains a powder and mixing solution which, when combined, provides a mouldable cohesive paste for introduction into a syringe. When injected the mixture sets to form Genex® Bone Graft Substiute, a hard but resorbable matrix. Genex® Bone Graft Substitute is supplied sterile.
Device Class : 2
Duns Number: 424382307
Premarket Exempt : No
Prescription Use : Yes
Device Description : Genex® Bone Graft Substitute is a simple to use synthetic resorbable material de Genex® Bone Graft Substitute is a simple to use synthetic resorbable material designed to promote regeneration of bone in osseous defects. It degrades into component elements normally found in the body and is highly biocompatible.The kit contains a powder and mixing solution which, when combined, provides a mouldable cohesive paste for introduction into a syringe. When injected the mixture sets to form Genex® Bone Graft Substitute a hard but resorbable matrix. Genex® Bone Graft Substitute is supplied sterile.
Device Class : 2
Duns Number: 424382307
Premarket Exempt : No
Prescription Use : Yes
Device Description : STIMULAN® Rapid Cure provided sterile for single patient use. STIMULAN® Rapid Cu STIMULAN® Rapid Cure provided sterile for single patient use. STIMULAN® Rapid Cure contains calcium sulfate powder and mixing solution in pre-measured quantities so that when mixed together in a sterile mixing bowl, the resultant paste is to be digitally packed into open bone void/gap to set insitu or placed into the mould provided, the mixture sets to form beads. The biodegradable, radiopaque beads are resorbed in approximately 30 – 60 days when used in accordance with the device labelling. STIMULAN® Rapid Cure is manufactured from synthetic implant grade calcium sulfate dihydrate(CaSO4.2H2O) that resorbs and is replaced with bone during the healing process. Also, as the bone void filler beads are biodegradable and biocompatible, they may be used at an infected site.
Device Class : 2
Duns Number: 424382307
Premarket Exempt : No
Prescription Use : Yes
Device Description : genex® Bone Graft Substitute is a simple to use synthetic absorbable material de genex® Bone Graft Substitute is a simple to use synthetic absorbable material designed to promote regeneration of bone in osseous defects. It degrades into component elements normally found in the body and is highly biocompatible. The kit contains a powder filled syringe and mixing solution which, when combined, provides a mouldablecohesive paste which may be implanted into open voids/gaps of the musculoskeletal system to set in situ or placed in the bead mould mat provided to form beads for implantation. When injected the mixture sets to form genex® Bone Graft substitute a hard but absorbable matrix. genex® Bone Graft Substituteis supplied sterile. genex® Bone Graft Substitute , accessories and packaging are not made from natural rubber latex. genex® Bone Graft Substitute is MR safe.
Device Class : 2
Duns Number: 424382307
Premarket Exempt : No
Prescription Use : Yes
Device Description : genex® Bone Graft Substitute is a simple to use synthetic absorbable material de genex® Bone Graft Substitute is a simple to use synthetic absorbable material designed to promote regeneration of bone in osseous defects. It degrades into component elements normally found in the body and is highly biocompatible. The kit contains a powder filled syringe and mixing solution which, when combined, provides a mouldablecohesive paste which may be implanted into open voids/gaps of the musculoskeletal system to set insitu or placed in the bead mould mat provided to form beads for implantation. When injected the mixturesets to form genex® Bone Graft substitute a hard but absorbable matrix. genex® Bone Graft Substituteis supplied sterile. genex® Bone Graft Substitute , accessories and packaging are not made from natural rubber latex.genex® Bone Graft Substitute is MR safe.
Device Class : 2
Duns Number: 424382307
Premarket Exempt : No
Prescription Use : Yes
Device Description : genex® Bone Graft Substitute is a simple to use synthetic absorbable material de genex® Bone Graft Substitute is a simple to use synthetic absorbable material designed to promote regeneration of bone in osseous defects. It degrades into component elements normally found in the body and is highly biocompatible. The kit contains a powder filled syringe and mixing solution which, when combined, provides a mouldablecohesive paste which may be implanted into open voids/gaps of the musculoskeletal system to set insitu or placed in the bead mould mat provided to form beads for implantation. When injected the mixturesets to form genex® Bone Graft substitute a hard but absorbable matrix. genex® Bone Graft Substituteis supplied sterile. genex® Bone Graft Substitute , accessories and packaging are not made from natural rubber latex.genex® Bone Graft Substitute is MR safe.
Device Class : 2
Duns Number: 424382307
Premarket Exempt : No
Prescription Use : Yes