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Nuvasive NuVasive® Pulse System - HSA Registration DE0508020

Access comprehensive regulatory information for Nuvasive NuVasive® Pulse 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 DE0508020 and owned by Nuvasive Inc. The device was registered on April 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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CLASS C
DE0508020
Nuvasive NuVasive® Pulse System
HSA Registration Number: DE0508020
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Product Description

The Pulse System is a medical device comprised of Pulse NVM5, Pulse LessRay, and Pulse Navigation. The Pulse NVM5 is intended for intraoperative neurophysiologic monitoring during spinal surgery, neck dissections, thoracic surgeries, and upper and lower extremities. The device provides information directly to the surgeon, to help assess a patient’s neurophysiologic status. The System also integrates Bendini software used to locate spinal implant instrumentation for the placement of spinal rods. The Bendini Spinal Rod Bending function is used to locate spinal implant system instrumentation to determine their relative location to one another to generate bend instructions to shape a spinal rod. Pulse LessRay is intended for use in any application where a fluoroscope is incorporated to aid in diagnosis and treatment of disease. Pulse Navigation is intended as an intraoperative image-guided localization system in either open or minimally-invasive spinal surgical procedures.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Orthopaedics
Registration Information
Registration Number
DE0508020
Registration Date
April 20, 2023
Change Notification Approval Date
July 05, 2023
Retention Due Date
April 19, 2026
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)
Pulse Software Package including IOM, iG Pulse SW with IOM, iGA, BEN, LR, and NAV PULSE Patient Module 4 PULSE Spare Needle Electrodes, 2 Pack Pulse II Touchsceen Monitor PULSE III System NV I-PAS III, Diamond Tip NV I-PAS III, Beveled Tip Sterile NVJJB Sheath, Dynamic Stimulation Ster PULSE Camera Stimulation Probe, Monopolar Stimulation Clip-Activator, Single EMG Electrode Kit, Needle MIOM Electrode Kit, Needle PULSE TMAP Kit PULSE Hip Pin Kit, 10cm PULSE Hip Pin Kit, 15cm
Model Identifier(s)
1802490 1802494 1830010 1840180 1881050 1881500 2010028 2010029 2010036 5000504 50110101 50110201 50120101 50120104 50120401 5050310 5050315