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Stryker TPX System - HSA Registration DE0504815

Access comprehensive regulatory information for Stryker TPX System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0504815 and owned by Stryker Instruments. The device was registered on August 13, 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 B
DE0504815
Stryker TPX System
HSA Registration Number: DE0504815
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Product Description

The TPX System is intended for use with the Consolidated Operating Room Equipment (COREโ„ข) System. When used with a variety of cutting accessories and/or compatible attachments, it is intended for cutting, drilling, reaming, decorticating, shaping, and smoothing of bone, hard tissues, bone cement, and teeth in a variety of surgical procedures. This includes but is not limited to Orthopedic, Dental, ENT (Ear, Nose, Throat), Neuro, Spine and Endoscopic applications. It is also usable in placement or cutting of screws, metal, wires, pins, and other fixation devices.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0504815
Registration Date
August 13, 2020
Change Notification Approval Date
June 27, 2024
Retention Due Date
August 12, 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
47 JALAN BUROH, #09-01, SINGAPORE 619491 11 LORONG 3 TOA PAYOH, JACKSON SQUARE, #01-13, SINGAPORE 319579 1 GEORGE STREET, ONE GEORGE STREET, #20-1/2/3, SINGAPORE 049145
Model Information
Model Name(s)
1.5 x 8mm TPXโ„ข Router 1.5 x 12mm TPXโ„ข Router 1.5 x 20mm TPXโ„ข Router 1.5 x 30mm TPXโ„ข Router TPXโ„ข Micro Drill TPXโ„ข Oscillating Saw TPXโ„ข Sagittal Saw TPXโ„ข Reciprocating Saw TPXโ„ข Wiredriver TPXโ„ข Universal Driver TPXโ„ข XL Oscillating Saw
Model Identifier(s)
6515-008-000 6515-012-000 6515-020-000 6515-030-000 7400-015-000 7400-031-000 7400-034-000 7400-037-000 7400-062-000 7400-099-000 7400-131-000