Singapore HSA registration DE0507921
NuVasive Modulus ALIF System
Singapore·CLASS C·Nuvasive Inc·Registered March 20, 2023Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- Orthopaedics
Registration information
- Registration Number
- DE0507921
- Registration Date
- March 20, 2023
- Retention Due Date
- March 19, 2026
Product description
The NuVasive Modulus ALIF System is intended for use in interbody fusions in the lumbar spine from L2 to S1, following discectomy in the treatment of symptomatic degenerative disc disease (DDD) or degenerative spondylolisthesis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Modulus ALIF System implants can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis; however, when used in these patients at multiple levels and for patients with degenerative spondylolistheses, the Modulus ALIF System must be used with a supplemental internal spinal fixation system (e.g., pedicle screw system) for use in the lumbar spine in addition to the integrated screws.
Product Owner
- Name
- Nuvasive Inc
- 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)
- Modulus ALIF Bolt, Ø5.0x15mm Fix/2PK Modulus ALIF Bolt, Ø5.0x17.5mm Fix/2PK Modulus ALIF Bolt, Ø5.0x20mm Fix/2PK Modulus ALIF Bolt, Ø5.0x22.5mm Fix/2PK Modulus ALIF Bolt, Ø5.0x25mm Fix/2PK Modulus ALIF Bolt, Ø6.0x15mm Fix/2PK Modulus ALIF Bolt, Ø6.0x17.5mm Fix/2PK Modulus ALIF Bolt, Ø6.0x20mm Fix/2PK Modulus ALIF Bolt, Ø6.0x22.5mm Fix/2PK Modulus ALIF Bolt, Ø6.0x25mm Fix/2PK Modulus ALIF Bolt, Ø5.0x15mm Fixation Modulus ALIF Bolt, Ø5.0x17.5mm Fixation Modulus ALIF Bolt, Ø5.0x20mm Fixation Modulus ALIF Bolt, Ø5.0x22.5mm Fixation Modulus ALIF Bolt, Ø5.0x25mm Fixation Modulus ALIF Bolt, Ø6.0x15mm Fixation Modulus ALIF Bolt, Ø6.0x17.5mm Fixation Modulus ALIF Bolt, Ø6.0x20mm Fixation Modulus ALIF Bolt, Ø6.0x22.5mm Fixation Modulus ALIF Bolt, Ø6.0x25mm Fixation Modulus ALIF, 6x34x24mm 10° Modulus ALIF, 8x34x24mm 10° Modulus ALIF, 10x34x24mm 10° Modulus ALIF, 6x34x24mm 15° Modulus ALIF, 8x34x24mm 15° Modulus ALIF, 10x34x24mm 15° Modulus ALIF, 6x34x24mm 20° Modulus ALIF, 8x34x24mm 20° Modulus ALIF, 10x34x24mm 20° Modulus ALIF HL, 6x34x24mm 25° Modulus ALIF HL, 8x34x24mm 25° Modulus ALIF HL, 10x34x24mm 25° Modulus ALIF HL, 6x34x24mm 30° Modulus ALIF HL, 8x34x24mm 30° Modulus ALIF HL, 10x34x24mm 30° Modulus ALIF, 6x34x28mm 10° Modulus ALIF, 8x34x28mm 10° Modulus ALIF, 10x34x28mm 10° Modulus ALIF, 6x34x28mm 15° Modulus ALIF, 8x34x28mm 15° Modulus ALIF, 10x34x28mm 15° Modulus ALIF, 6x34x28mm 20° Modulus ALIF, 8x34x28mm 20° Modulus ALIF, 10x34x28mm 20° Modulus ALIF, 6x38x28mm 10° Modulus ALIF, 8x38x28mm 10° Modulus ALIF, 10x38x28mm 10° Modulus ALIF, 6x38x28mm 15° Modulus ALIF, 8x38x28mm 15° Modulus ALIF, 10x38x28mm 15° Modulus ALIF, 6x38x28mm 20° Modulus ALIF, 8x38x28mm 20° Modulus ALIF, 10x38x28mm 20° Modulus ALIF HL, 6x38x28mm 25° Modulus ALIF HL, 8x38x28mm 25° Modulus ALIF HL, 10x38x28mm 25° Modulus ALIF HL, 6x38x28mm 30° Modulus ALIF HL, 8x38x28mm 30° Modulus ALIF, 6x42x32mm 10° Modulus ALIF, 8x42x32mm 10° Modulus ALIF, 10x42x32mm 10° Modulus ALIF, 6x42x32mm 15° Modulus ALIF, 8x42x32mm 15° Modulus ALIF, 10x42x32mm 15° Modulus ALIF, 6x42x32mm 20° Modulus ALIF, 8x42x32mm 20° Modulus ALIF, 10x42x32mm 20° Modulus ALIF HL, 6x42x32mm 25° Modulus ALIF HL, 8x42x32mm 25° Modulus ALIF HL, 10x42x32mm 25° Modulus ALIF HL, 6x42x32mm 30° Modulus ALIF HL, 8x42x32mm 30°
- Model Identifier(s)
- 1350150P2 1350175P2 1350200P2 1350225P2 1350250P2 1360150P2 1360175P2 1360200P2 1360225P2 1360250P2 1450150 1450175 1450200 1450225 1450250 1460150 1460175 1460200 1460225 1460250 1921001P2 1921002P2 1921003P2 1921005P2 1921006P2 1921007P2 1921009P2 1921010P2 1921011P2 1921013P2 1921014P2 1921015P2 1921017P2 1921018P2 1921019P2 1921021P2 1921022P2 1921023P2 1921025P2 1921026P2 1921027P2 1921029P2 1921030P2 1921031P2 1921041P2 1921042P2 1921043P2 1921045P2 1921046P2 1921047P2 1921049P2 1921050P2 1921051P2 1921053P2 1921054P2 1921055P2 1921057P2 1921058P2 1921081P2 1921082P2 1921083P2 1921085P2 1921086P2 1921087P2 1921089P2 1921090P2 1921091P2 1921093P2 1921094P2 1921095P2 1921097P2 1921098P2
About this record
Access comprehensive regulatory information for NuVasive Modulus ALIF 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 DE0507921 and owned by Nuvasive Inc. The device was registered on March 20, 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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