BIOCOMPOSITES LTD

Address:KEELE SCIENCE PARK,Keele Staffordshire,GB

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- Catalog Number : 640-005

Device Description : Stimulan® DS Calcium Sulfate Bone Void Filler is provided sterile for single pat Stimulan® DS Calcium Sulfate Bone Void Filler is provided sterile for single patient use. The kit contains calcium sulfate powder and mixing solution in pre-measured quantities so that when mixed together, the resultant paste is to be injected or digitally packed into open bone/gap to cure insitu. The biodegradable, radiopaque mixture is resorbed in approximately 30-60 days when used in accordance with the device labelling. Stimulan® is manufactured from synthetic implant grade calcium sulfate dihydrate (CaS04, 2H20) that resporbs and is replaced with bone during the healing process. Also as the bone void filler is biodegradable and biocompatible; it may be used at an infected site.

Device Class : 2

Duns Number: 424382307

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

- Catalog Number : 3910-200-080

Device Description : The Biosteon® IntraLine 4.5mm HA/PLLA Suture Anchor with two #2 Force Fibre®, is The Biosteon® IntraLine 4.5mm HA/PLLA Suture Anchor with two #2 Force Fibre®, is a single use device. It is made from a resorbable composite which will gradually be resorbed into the body. This function however is patient dependent. The device is supplied sterile. The device is intended to secure a suture or sutures to bone that are then used to reattach damaged soft tissue in orthopaedic procedures in the shoulder, foot/ankle, knee, hand/wrist, elbow and pelvis. The device is supplied with polyethylene sutures.

Device Class :

Duns Number: 424382307

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

- Catalog Number : 3910-200-081

Device Description : The Biosteon® IntraLine® 5.5mm HA/PLLA Suture Anchor with two #2 Force Fibre®, i The Biosteon® IntraLine® 5.5mm HA/PLLA Suture Anchor with two #2 Force Fibre®, is a single use device. It is made from a resorbable composite which will gradually be resorbed into the body. This function however is patient dependent. The device is supplied sterile. The device is intended to secure a suture or sutures to bone that are then used to reattach damaged soft tissue in orthopaedic procedures in the shoulder, foot/ankle, knee, hand/wrist, elbow and pelvis. The device is supplied with polyethylene sutures.

Device Class : 2

Duns Number: 424382307

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

- Catalog Number : 3910-200-082

Device Description : The Biosteon® IntraLine® 5.5mm HA/PLLA Needled Suture Anchor with two #2 Force F The Biosteon® IntraLine® 5.5mm HA/PLLA Needled Suture Anchor with two #2 Force Fibre®, is a single use device. It is made from a resorbable composite which will gradually be resorbed into the body. This function however is patient dependent. The device is supplied sterile. The device is intended to secure a suture or sutures to bone that are then used to reattach damaged soft tissue in orthopaedic procedures in the shoulder, foot/ankle, knee, hand/wrist, elbow and pelvis. The device is supplied with stainless steel needles and polyethylene sutures.

Device Class :

Duns Number: 424382307

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

- Catalog Number : 3910-200-083

Device Description : The Biosteon® IntraLine® 5.5mm HA/PLLA Suture Anchor with three #2 Force Fibre®, The Biosteon® IntraLine® 5.5mm HA/PLLA Suture Anchor with three #2 Force Fibre®, is a single use device. It is made from a resorbable composite which will gradually be resorbed into the body. This function however is patient dependent. The device is supplied sterile. The device is intended to secure a suture or sutures to bone that are then used to reattach damaged soft tissue in orthopaedic procedures in the shoulder, foot/ankle, knee, hand/wrist, elbow and pelvis. The device is supplied with polyethylene sutures.

Device Class :

Duns Number: 424382307

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

- Catalog Number : 3910-200-084

Device Description : The Biosteon® IntraLine® 6.5mm HA/PLLA Suture Anchor with two #2 Force Fibre®, i The Biosteon® IntraLine® 6.5mm HA/PLLA Suture Anchor with two #2 Force Fibre®, is a single use device. It is made from a resorbable composite which will gradually be resorbed into the body. This function however is patient dependent. The device is supplied sterile. The device is intended to secure a suture or sutures to bone that are then used to reattach damaged soft tissue in orthopaedic procedures in the shoulder, foot/ankle, knee, hand/wrist, elbow and pelvis. The device is supplied with polyethylene sutures.

Device Class :

Duns Number: 424382307

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

- Catalog Number : 3910-200-085

Device Description : The Biosteon® IntraLine® 6.5mm HA/PLLA Needled Suture Anchor with two #2 Force F The Biosteon® IntraLine® 6.5mm HA/PLLA Needled Suture Anchor with two #2 Force Fibre®, is a single use device. It is made from a resorbable composite which will gradually be resorbed into the body. This function however is patient dependent. The device is supplied sterile. The device is intended to secure a suture or sutures to bone that are then used to reattach damaged soft tissue in orthopaedic procedures in the shoulder, foot/ankle, knee, hand/wrist, elbow and pelvis. The device is supplied with stainless steel needles and polyethylene sutures.

Device Class : 2

Duns Number: 424382307

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

- Catalog Number : 3910-200-086

Device Description : The Biosteon® IntraLine® 6.5mm HA/PLLA Suture Anchor with three #2 Force Fibre®, The Biosteon® IntraLine® 6.5mm HA/PLLA Suture Anchor with three #2 Force Fibre®, is a single use device. It is made from a resorbable composite which will gradually be resorbed into the body. This function however is patient dependent. The device is supplied sterile. The device is intended to secure a suture or sutures to bone that are then used to reattach damaged soft tissue in orthopaedic procedures in the shoulder, foot/ankle, knee, hand/wrist, elbow and pelvis. The device is supplied with polyethylene sutures.

Device Class :

Duns Number: 424382307

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

- Catalog Number : 234-010-160

Device Description : The Biosteon® ACL Screw is a cannulated, single-use bone screw made of a resorba 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 dependent.

Device Class : 2

Duns Number: 424382307

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

- Catalog Number : 234-010-170

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

Product Code : HWC

Prescription Use : Yes

Device Count : 1