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Stryker System 8 - HSA Registration DE0502028

Access comprehensive regulatory information for Stryker System 8 in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0502028 and owned by Stryker Instruments. The device was registered on August 14, 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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CLASS B
DE0502028
Stryker System 8
HSA Registration Number: DE0502028
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Product Description

The Stryker System 8 is designed for general surgical use where hard tissue and/or bone must be cut, reamed, drilled, decorticated, and/or fixated with screws, including but not limited to the hand, wrist, elbow, sternum, shoulder, foot, ankle, knee and hip. It is also usable in the placement of screws, wires, pins, and other fixation devices.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0502028
Registration Date
August 14, 2018
Change Notification Approval Date
October 17, 2021
Retention Due Date
August 13, 2025
Product Owner
Short Name
Stryker Instruments
Address
1941 Stryker Way, Portage MI 49002, UNITED STATES
Registrant
Address
1 GEORGE STREET, ONE GEORGE STREET, #20-1/2/3, SINGAPORE 049145
Importer
Address
1 GEORGE STREET, ONE GEORGE STREET, #20-1/2/3, SINGAPORE 049145
Model Information
Model Name(s)
System 8 Cordless Driver Handpiece System 8 Sabo Sagittal Saw EZout Attachment EZout Centering Plug, 34mm EZout Centering Plug, 36mm EZout Centering Plug, 38mm EZout Centering Plug, 40mm EZout Centering Plug, 41mm EZout Centering Plug, 42mm EZout Centering Plug, 43mm EZout Centering Plug, 44mm EZout Centering Plug, 45mm EZout Centering Plug, 46mm EZout Centering Plug, 47mm EZout Centering Plug, 48mm EZout Centering Plug, 49mm EZout Centering Plug, 50mm EZout Centering Plug, 51mm EZout Centering Plug, 52mm EZout Centering Plug, 54mm EZout Centering Plug, 56mm EZout Centering Plug, 58mm EZout Centering Plug, 60mm EZout Riser Ring, 34-36 mm EZout Riser Ring, 38-40 mm EZout Riser Ring, 41-43 mm EZout Riser Ring, 44-46mm EZout Riser Ring, 47-49mm EZout Riser Ring, 50-52mm EZout Riser Ring, 54-56mm EZout Riser Ring, 58-60mm EZout Blade Sizing Tool, 42-50 mm EZout Blade Sizing Tool, 50-58 mm EZout Blade Sizing Tool, 58-66 mm EZout Blade Sizing Tool, 66-74 mm EZout Trial Rod EZout Plug Sizing Template, 34-47 mm EZout Plug Sizing Template, 48-60 mm EZout Accessories Kit Long Sternum Blade Guard Sternum Blade Guard EZout Blade Pack, 42mm EZout Blade Pack, 44mm EZout Blade Pack, 46mm EZout Blade Pack, 48mm EZout Blade Pack, 50mm EZout Blade Pack, 52mm EZout Blade Pack, 54mm EZout Blade Pack, 56mm EZout Blade Pack, 58mm EZout Blade Pack, 60mm EZout Blade Pack, 62mm EZout Blade Pack, 64mm EZout Blade Pack, 66mm EZout Blade Pack, 68mm EZout Blade Pack, 70mm EZout Blade Pack, 72mm EZout Blade Pack, 74mm System 8 Ezout Saw System 8 EZout System System 8 Single Trigger Rotary Handpiece System 8 Dual Trigger Rotary Handpiece System 8 Reciprocating Saw System 8 Sternum Saw System 8 Sagittal Saw System 8 Stryker Precision Saw
Model Identifier(s)
4505-000-000 4508-000-000 7202-100-000 7202-200-034 7202-200-036 7202-200-038 7202-200-040 7202-200-041 7202-200-042 7202-200-043 7202-200-044 7202-200-045 7202-200-046 7202-200-047 7202-200-048 7202-200-049 7202-200-050 7202-200-051 7202-200-052 7202-200-054 7202-200-056 7202-200-058 7202-200-060 7202-200-134 7202-200-138 7202-200-141 7202-200-144 7202-200-147 7202-200-150 7202-200-154 7202-200-158 7202-300-042 7202-300-050 7202-300-058 7202-300-066 7202-300-100 7202-300-134 7202-300-148 7202-999-001 7207-002-000 7207-003-000 7812-042-001K 7812-044-001K 7812-046-001K 7812-048-001K 7812-050-001K 7812-052-001K 7812-054-001K 7812-056-001K 7812-058-001K 7812-060-001K 7812-062-001K 7812-064-001K 7812-066-001K 7812-068-001K 7812-070-001K 7812-072-001K 7812-074-001K 8202-000-000 8202-999-000 8203-000-000 8205-000-000 8206-000-000 8207-000-000 8208-000-000 8209-000-000