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Singapore HSA registration DE0507891

NUVASIVE MODULUS-C INTERBODY SYSTEM

Singapore flagSingapore·CLASS C·Nuvasive Inc·Registered March 13, 2023
Device classification
Device Class
CLASS C
Medical Speciality Area
Orthopaedics
Registration information
Registration Number
DE0507891
Registration Date
March 13, 2023
Retention Due Date
March 12, 2026
Product description
The NuVasive Modulus-C Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The Modulus-C Interbody System is intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. The System is intended to be used with supplemental fixation. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous, cortical and/or corticocancellous bone graft to facilitate fusion.
Product Owner
Name
Nuvasive Inc
Short Name
Nuvasive
Address
7475 Lusk Blvd, San Diego, CA 92121, UNITED STATES
Registrant
Name
NUVASIVE SOUTHEAST ASIA PTE. LTD.
Address
151 LORONG CHUAN, NEW TECH PARK, #04-03, SINGAPORE 556741
Importer
Name
NUVASIVE SOUTHEAST ASIA PTE. LTD.
Address
151 LORONG CHUAN, NEW TECH PARK, #04-03, SINGAPORE 556741
Model information
Model Name(s)
Modulus Cervical, 5x15x12mm 7° Modulus Cervical, 6x15x12mm 7° Modulus Cervical, 7x15x12mm 7° Modulus Cervical, 8x15x12mm 7° Modulus Cervical, 9x15x12mm 7° Modulus Cervical, 10x15x12mm 7° Modulus Cervical, 5x15x12mm 10° Modulus Cervical, 6x15x12mm 10° Modulus Cervical, 7x15x12mm 10° Modulus Cervical, 8x15x12mm 10° Modulus Cervical, 9x15x12mm 10° Modulus Cervical, 10x15x12mm 10° Modulus Cervical, 5x17x14mm 7° Modulus Cervical, 6x17x14mm 7° Modulus Cervical, 7x17x14mm 7° Modulus Cervical, 8x17x14mm 7° Modulus Cervical, 9x17x14mm 7° Modulus Cervical, 10x17x14mm 7° Modulus Cervical, 6x17x14mm 10° Modulus Cervical, 7x17x14mm 10° Modulus Cervical, 8x17x14mm 10° Modulus Cervical, 9x17x14mm 10° Modulus Cervical, 10x17x14mm 10° Modulus Cervical, 5x19x16mm 7° Modulus Cervical, 6x19x16mm 7° Modulus Cervical, 7x19x16mm 7° Modulus Cervical, 8x19x16mm 7° Modulus Cervical, 9x19x16mm 7° Modulus Cervical, 10x19x16mm 7° Modulus Cervical, 6x19x16mm 10° Modulus Cervical, 7x19x16mm 10° Modulus Cervical, 8x19x16mm 10° Modulus Cervical, 9x19x16mm 10° Modulus Cervical, 10x19x16mm 10°
Model Identifier(s)
67940000P2 67940001P2 67940002P2 67940003P2 67940004P2 67940005P2 67940012P2 67940013P2 67940014P2 67940015P2 67940016P2 67940017P2 67940035P2 67940036P2 67940037P2 67940038P2 67940039P2 67940040P2 67940047P2 67940048P2 67940049P2 67940050P2 67940051P2 67940068P2 67940069P2 67940070P2 67940071P2 67940072P2 67940073P2 67940080P2 67940081P2 67940082P2 67940083P2 67940084P2
About this record

Access comprehensive regulatory information for NUVASIVE MODULUS-C 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 DE0507891 and owned by Nuvasive Inc. The device was registered on March 13, 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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