NuVasive Cohere TLIF-O Thoracolumbar Interbody System

Pays: Singapour

Langue: anglais

Source: HSA (Health Sciences Authority)

Disponible depuis:

NUVASIVE SOUTHEAST ASIA PTE. LTD.

classe:

Class C medical device

Fabriqué par:

Nuvasive Inc

Domaine thérapeutique:

Orthopaedics

indications thérapeutiques:

The NuVasive Cohere Thoracolumbar Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. When used with or without the Cohere XLIF internal fixation, the system is indicated for use with supplemental spinal fixation systems for use in the thoracolumbar spine. The devices are to be used in patients who have had at least six months of non-operative treatment. The NuVasive Cohere Thoracolumbar Interbody System is intended for use in interbody fusions in the thoracic spine, from T1 to T12, and at the thoracolumbar junction (T12-L1), and in the lumbar spine, from L1 to S1, for the treatment of symptomatic disc disease (DDD) or degenerative spondylolisthesis at one or two adjacent levels, including thoracic disc herniation (with myelopathy and/or radiculopathy with or without axial pain). DDD is defined as bac

Descriptif du produit:

Device System Info:[Sterile Medical Device], GAMMA RADIATION; Models: COHERE TLIF-O, 16x10x25mm 12° - 6160252P2, COHERE TLIF-O, 16x10x25mm 4° - 6160254P2, COHERE TLIF-O, 16x10x25mm 8° - 6160258P2, COHERE TLIF-O, 16x10x30mm 12° - 6160302P2, COHERE TLIF-O, 14x10x30mm 12° - 6140302P2, COHERE TLIF-O, 14x10x25mm 8° - 6140258P2, COHERE TLIF-O, 14x10x25mm 4° - 6140254P2, COHERE TLIF-O, 14x10x25mm 12° - 6140252P2, COHERE TLIF-O, 14x14x30mm 4° - 6144304P2, COHERE TLIF-O, 14x10x35mm 4° - 6140354P2, COHERE TLIF-O, 14x10x30mm 8° - 6140308P2, COHERE TLIF-O, 16x10x30mm 4° - 6160304P2, COHERE TLIF-O, 16x10x30mm 8° - 6160308P2, COHERE TLIF-O, 18x10x25mm 12° - 6180252P2, COHERE TLIF-O, 18x10x30mm 12° - 6180302P2, COHERE TLIF-O, 18x10x30mm 8° - 6180308P2, COHERE TLIF-O, 14x10x30mm 4° - 6140304P2, COHERE TLIF-O, 10x10x35mm 4° - 6100354P2, COHERE TLIF-O, 10x14x30mm 4° - 6104304P2, COHERE TLIF-O, 11x10x30mm 8° - 6110308P2, COHERE TLIF-O, 12x10x25mm 12° - 6120252P2, COHERE TLIF-O, 12x10x25mm 4° - 6120254P2, COHERE TLIF-O, 12x10x25mm 8° - 6120258P2, COHERE TLIF-O, 12x10x30mm 12° - 6120302P2, COHERE TLIF-O, 12x10x30mm 4° - 6120304P2, COHERE TLIF-O, 12x10x30mm 8° - 6120308P2, COHERE TLIF-O, 12x10x35mm 4° - 6120354P2, COHERE TLIF-O, 12x14x30mm 4° - 6124304P2, COHERE TLIF-O, 10x10x30mm 4° - 6100304P2, COHERE TLIF-O, 10x10x25mm 4° - 6100254P2

Date de l'autorisation:

2023-08-18