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Smith & Nephew JET-X MINI External Fixator System - HSA Registration DE0504903

Access comprehensive regulatory information for Smith & Nephew JET-X MINI External Fixator 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 DE0504903 and owned by Smith & Nephew, Inc.. The device was registered on September 11, 2020.

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
DE0504903
Smith & Nephew JET-X MINI External Fixator System
HSA Registration Number: DE0504903
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Product Description

Mini external fixator systems are indicated for the management of comminuted intra-articular fractures of the distal radius

Device Classification
Device Class
CLASS C
Medical Speciality Area
Orthopaedics
Registration Information
Registration Number
DE0504903
Registration Date
September 11, 2020
Change Notification Approval Date
May 15, 2024
Retention Due Date
September 10, 2025
Product Owner
Short Name
Smith & Nephew, Inc.
Address
1450 Brooks Road, Memphis, Tennessee, 38116, UNITED STATES
Registrant
Address
29 MEDIA CIRCLE, ALICE@MEDIAPOLIS, #06-05, SINGAPORE 138565
Importer
Address
29 MEDIA CIRCLE, ALICE@MEDIAPOLIS, #06-05, SINGAPORE 138565 29 MEDIA CIRCLE, ALICE@MEDIAPOLIS, #06-05, SINGAPORE 138565
Model Information
Model Name(s)
Box Wrench SBF Protective Caps; Red for Threaded 4mm Pin Double Pin Clamp with Ball Joint Titanium Nitride Short Half Pin 3mm x 10mm Titanium Nitride Short Half Pin 3mm x 15mmm Titanium Nitride Short Half Pin 3mm x 20mm Distractor Clip Titanium Nitride Short Half Pin 3mm x 25mm Freedom Clamps 6mm Bar to 4mm Pin Freedom Clamps 6mm Bar to 6mm Pin Titanium Nitride Short Half Pin 4mm x 15mm Titanium Nitride Short Half Pin 4mm x 20mm Titanium Nitride Short Half Pin 4mm x 25mm Titanium Nitride Short Half Pin 4mm x 30mm Titanium Nitride Short Half Pin 4mm x 35mm JET-X MINI DISTAL RADIUS KIT Bar 6mm x 75mm Bar 6mm x 110mm Bar 6mm x 150mm Bar 6mm V Bar Bar 6mm x 185mm Bar 6mm x 225mm AO T-Handle Connector with 8mm Socket Trocar Tissue Protector Drill for 3mm Half Pin Drill for 4mm Half Pin 8mm Ratchet Wrench Quick Clamp Bar to in Drill Guide Mini Distal Radius 2.0mm Drill Tray
Model Identifier(s)
102915 290058 71062016 71063108 71063158 71063208 71063213 71063258 71064011 71064012 71064158 71064208 71064258 71064308 71064358 71064701 71065075 71065110 71065150 71065180 71065185 71065225 71067305 71067309 71067311 71067315 71067316 71067323 71067325 71067327 71067361