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NuVasive Magec System - HSA Registration DE0509357

Access comprehensive regulatory information for NuVasive Magec 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 DE0509357 and owned by NuVasive Specialized Orthopedics, Inc.. The device was registered on June 06, 2024.

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
DE0509357
NuVasive Magec System
HSA Registration Number: DE0509357
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Product Description

The MAGEC System is indicated for skeletally immature patients less than 10 years of age with severe progressive spinal deformities (e.g. Cobb angle of 30 degrees or more; thoracic spine height less than 22 cm) associated with or at risk of Thoracic Insufficiency Syndrome. TIS is defined as the inability of the thorax to support normal respiration or lung growth.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Orthopaedics
Registration Information
Registration Number
DE0509357
Registration Date
June 06, 2024
Retention Due Date
June 05, 2025
Product Owner
Short Name
NuVasive Specialized Orthopedics, Inc.
Address
101 Enterprise, Suite 100, California, 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)
MAGEC ERC2, Shipping Pkg AR MAGEC 2 Rod, 4.5mm 70mm Offsetย ย  MAGEC 2 Rod, 4.5mm 70mm Standard MAGEC 2 Rod, 4.5mm 90mm Offsetย ย  MAGEC 2 Rod, 4.5mm 90mm Standard MAGEC 2 Rod, 5.0mm 70mm Offset MAGEC 2 Rod, 5.0mm 70mm Standard MAGEC 2 Rod, 5.0mm 90mm Offset MAGEC 2 Rod, 5.0mm 90mm Standard MAGEC 2 Rod, 5.5mm 70mm Offsetย ย  MAGEC 2 Rod, 5.5mm 70mm Standard MAGEC 2 Rod, 5.5mm 90mm Offsetย ย  MAGEC 2 Rod, 5.5mm 90mm Standard MAGEC 2 Rod, 6.0mm 70mm Offset MAGEC 2 Rod, 6.0mm 70mm Standard MAGEC 2 Rod, 6.0mm 90mm Offset MAGEC 2 Rod, 6.0mm 90mm Standard MAGEC Manual Distractor MAGEC Wand MAGEC Rod Template, 70mm MAGEC Rod Template, 90mm
Model Identifier(s)
EAD-M1-001 MC2-4570R MC2-4570S MC2-4590R MC2-4590S MC2-5070R MC2-5070S MC2-5090R MC2-5090S MC2-5570R MC2-5570S MC2-5590R MC2-5590S MC2-6070R MC2-6070S MC2-6090R MC2-6090S MMD-003 MML-001 MR2-4070T MR2-4090T