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Singapore HSA registration DE0502338

Stryker SpineJack System

Singapore flagSingapore·CLASS C·Stryker Instruments·Registered November 13, 2018
Device classification
Device Class
CLASS C
Medical Speciality Area
Orthopaedics
Registration information
Registration Number
DE0502338
Registration Date
November 13, 2018
Change Notification Approval Date
April 25, 2024
Retention Due Date
November 12, 2025
Product description
The SpineJack system is indicated for use in the reduction of mobile spinal fractures that may result from osteoporosis, trauma (fractures types A according to the Magerl classification) and malignant lesions (myeloma or osteolitic metastasis). The SpineJack system is intended to be used in combination with validated bone cement, and to be placed, using a transpedicular approach, through a vertebra pedicle with a minimum diameter as verified with a pre-operative CT scan.
Product Owner
Name
Stryker Instruments
Short Name
Stryker Instruments
Address
1941 Stryker Way, Portage MI 49002, UNITED STATES
Registrant
Name
STRYKER SINGAPORE PRIVATE LIMITED
Address
1 GEORGE STREET, ONE GEORGE STREET, #20-1/2/3, SINGAPORE 049145
Importer
Name
STRYKER SINGAPORE PRIVATE LIMITED TRANSMEDIC PTE LTD
Address
1 GEORGE STREET, ONE GEORGE STREET, #20-1/2/3, SINGAPORE 049145 5 JALAN KILANG BARAT, PETRO CENTRE, #09-00, SINGAPORE 159349
Model information
Model Name(s)
SpineJack® Expansion Kit Ø5 SpineJack® Expansion Kit Ø4.2 SpineJack® Expansion Kit Ø5.8 SpineJack® Preparation Kit Ø5 SpineJack® Preparation Kit Ø4.2 SpineJack® Preparation Kit Ø5.8 4.2 mm Cement Pusher 4.2 mm Injector Transfer Tube 5.0-5.8 mm Cement Pusher 5.0-5.8 mm Injector Transfer Tube
Model Identifier(s)
KE001 KE004 KE058 KP001 KP004 KP058 TC04003 TC04004 TC05003 TC05004
About this record

Access comprehensive regulatory information for Stryker SpineJack 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 DE0502338 and owned by Stryker Instruments. The device was registered on November 13, 2018.

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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