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Singapore HSA registration DE0508311

Nuvasive Navigation. S XLIF Dilator Kit, Stimulated

Singapore flagSingapore·CLASS B·Nuvasive Inc·Registered July 19, 2023
Device classification
Device Class
CLASS B
Medical Speciality Area
Orthopaedics
Registration information
Registration Number
DE0508311
Registration Date
July 19, 2023
Retention Due Date
July 18, 2025
Product description
NuVasive Navigation.S Instruments are intended to be used during the preparation and placement of NuVasive screws (Reline, Reline C and VuePoint fixation systems) and disc preparation during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The device is designed for use with the Medtronic StealthStation System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
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)
Nuvasive Navigation. S XLIF Dilator Kit, Stimulated.
Model Identifier(s)
5029950
About this record

Access comprehensive regulatory information for Nuvasive Navigation. S XLIF Dilator Kit, Stimulated in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0508311 and owned by Nuvasive Inc. The device was registered on July 19, 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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