Singapore HSA registration DE0508411

NuVasive Cohere TLIF-O Thoracolumbar Interbody System

Singapore flagSingapore·CLASS C·Nuvasive Inc·Registered August 18, 2023
Device classification
Device Class
CLASS C
Medical Speciality Area
Orthopaedics
Registration information
Registration Number
DE0508411
Registration Date
August 18, 2023
Retention Due Date
August 17, 2025
Product description
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 back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The NuVasive Cohere Thoracolumbar Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.
Product Owner
Short Name
Nuvasive
Address
7475 Lusk Blvd, San Diego, CA 92121, UNITED STATES
Registrant
Address
151 LORONG CHUAN, NEW TECH PARK, #04-03, SINGAPORE 556741
Importer
Address
151 LORONG CHUAN, NEW TECH PARK, #04-03, SINGAPORE 556741
Model information
Model Name(s)
COHERE TLIF-O, 10x10x25mm 4° COHERE TLIF-O, 10x10x30mm 4° COHERE TLIF-O, 10x10x35mm 4° COHERE TLIF-O, 10x14x30mm 4° COHERE TLIF-O, 11x10x30mm 8° COHERE TLIF-O, 12x10x25mm 12° COHERE TLIF-O, 12x10x25mm 4° COHERE TLIF-O, 12x10x25mm 8° COHERE TLIF-O, 12x10x30mm 12° COHERE TLIF-O, 12x10x30mm 4° COHERE TLIF-O, 12x10x30mm 8° COHERE TLIF-O, 12x10x35mm 4° COHERE TLIF-O, 12x14x30mm 4° COHERE TLIF-O, 14x10x25mm 12° COHERE TLIF-O, 14x10x25mm 4° COHERE TLIF-O, 14x10x25mm 8° COHERE TLIF-O, 14x10x30mm 12° COHERE TLIF-O, 14x10x30mm 4° COHERE TLIF-O, 14x10x30mm 8° COHERE TLIF-O, 14x10x35mm 4° COHERE TLIF-O, 14x14x30mm 4° COHERE TLIF-O, 16x10x25mm 12° COHERE TLIF-O, 16x10x25mm 4° COHERE TLIF-O, 16x10x25mm 8° COHERE TLIF-O, 16x10x30mm 12° COHERE TLIF-O, 16x10x30mm 4° COHERE TLIF-O, 16x10x30mm 8° COHERE TLIF-O, 18x10x25mm 12° COHERE TLIF-O, 18x10x30mm 12° COHERE TLIF-O, 18x10x30mm 8°
Model Identifier(s)
6100254P2 6100304P2 6100354P2 6104304P2 6110308P2 6120252P2 6120254P2 6120258P2 6120302P2 6120304P2 6120308P2 6120354P2 6124304P2 6140252P2 6140254P2 6140258P2 6140302P2 6140304P2 6140308P2 6140354P2 6144304P2 6160252P2 6160254P2 6160258P2 6160302P2 6160304P2 6160308P2 6180252P2 6180302P2 6180308P2
About this record

Access comprehensive regulatory information for NuVasive Cohere TLIF-O Thoracolumbar Interbody System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0508411 and owned by Nuvasive Inc. The device was registered on August 18, 2023.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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