Singapore HSA registration DE0508020
Nuvasive NuVasive® Pulse System
Singapore·CLASS C·Nuvasive Inc·Registered April 20, 2023Device 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 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.
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)
- 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
About this record
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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