Australia - English - Department of Health (Therapeutic Goods Administration)

johnson & johnson medical pty ltd t/a depuy synthes - 37272 - fixation device, internal, spine, construct - a device that used to assist in stabilizing and or support or correct alignment of spinal vertebrae.

Australia - English - Department of Health (Therapeutic Goods Administration)

johnson & johnson medical pty ltd t/a depuy synthes - 38156 - ceramic femoral head prosthesis - a biolox delta ts ceramic femoral head is composed of a packaged biolox delta ceramic femoral head with metal tapered sleeve adapters. the biolox delta ts ceramic femoral head is manufactured from biolox delta alumina matrix composite ceramic. the biolox delta ts ceramic head is intended to allow assembly with depuy femoral hip stem tapers, either in a primary hip replacement surgery, or in revision hip replacement surgery with well-fixed femoral stems. the depuy delta taper sleeve (ts) ceramic femoral head is intended for use in total hip arthroplasty applications to replace the articular surface of the femoral head in primary hip surgery and for the salvage of a failed previous hip surgery. total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. total hip replacement is indicated in the following conditions: 1. a severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. avascular necrosis of the femoral head. 3. acute traumatic fracture of the femoral head or neck. 4. failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. 5. certain cases of ankylosis.

Australia - English - Department of Health (Therapeutic Goods Administration)

johnson & johnson medical pty ltd t/a depuy synthes - 43257 - fixation system, internal, spinal, bone screw - to provide immobilisation and stabilisation of spinal segments in the treatment of instabilities or deformities of the thoracic, lumbar, and sacral spine.

Singapore - English - HSA (Health Sciences Authority)

johnson & johnson pte ltd - orthopaedics - intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

Singapore - English - HSA (Health Sciences Authority)

johnson & johnson pte ltd - orthopaedics - intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

Australia - English - Department of Health (Therapeutic Goods Administration)

johnson & johnson medical pty ltd t/a depuy synthes - 35217 - cement, orthopaedic, bone - indicated for the use of fixation of prosthesis to living bone arthroplasty procedures of joints in which infection by gentamicin sensitive organisms is a potential risk. the bone cement should be used with an appropriate prosthesis. indicated for the use of fixation of prosthesis to living bone arthroplasty procedures of joints in which infection by gentamicin sensitive organisms is a potential risk. the bone cement should be used with an appropriate prosthesis.

Australia - English - Department of Health (Therapeutic Goods Administration)

johnson & johnson medical pty ltd t/a depuy synthes - 35217 - cement, orthopaedic, bone - indicated for the use of fixation of prosthesis to living bone arthroplasty procedures of joints in which infection by gentamicin sensitive organisms is a potential risk. the bone cement should be used with an appropriate prosthesis. indicated for the use of fixation of prosthesis to living bone arthroplasty procedures of joints in which infection by gentamicin sensitive organisms is a potential risk. the bone cement should be used with an appropriate prosthesis.

Australia - English - Department of Health (Therapeutic Goods Administration)

johnson & johnson medical pty ltd t/a depuy synthes - 35217 - cement, orthopaedic, bone - indicated for the use of fixation of prosthesis to living bone arthroplasty procedures of joints in which infection by gentamicin sensitive organisms is a potential risk. the bone cement should be used with an appropriate prosthesis. indicated for the use of fixation of prosthesis to living bone arthroplasty procedures of joints in which infection by gentamicin sensitive organisms is a potential risk. the bone cement should be used with an appropriate prosthesis.

Australia - English - Department of Health (Therapeutic Goods Administration)

johnson & johnson medical pty ltd t/a depuy synthes - 45062 - soft-tissue anchor, non-bioabsorbable - the mitek fastin rc threaded titanium alloy anchor is preloaded on a disposable inserter assembly, with orthocord partially-absorbable sutures, supplied with or without needles - shoulder: rotator cuff repair, biceps tenodesis, acromio-clavicular separation repair and slap repair - foot/ankle: lateral stabilisation, medial stabilisation, achilles tendon repair - knee: medial collateral ligament repair, patellar tendon repair, posterior oblique ligament repair, iliotibial band tenodesis - elbow: biceps tendon reattachment, tennis elbow, ulnar or radial collateral ligament reconstruction

Australia - English - Department of Health (Therapeutic Goods Administration)

johnson & johnson medical pty ltd t/a depuy synthes - 45062 - soft-tissue anchor, non-bioabsorbable - the mitek fastin rc threaded titanium alloy anchor is preloaded on a disposable inserter assembly, with panacryl absorbable sutures, supplied with or without needles - shoulder: rotator cuff repair, biceps tenodesis, acromio-clavicular separation repair and slap repair - foot/ankle: lateral stabilisation, medial stabilisation, achilles tendon repair - knee: medial collateral ligament repair, patellar tendon repair, posterior oblique ligament repair, iliotibial band tenodesis - elbow: biceps tendon reattachment, tennis elbow, ulnar or radial collateral ligament reconstruction