Singapore HSA registration DE0504815
Stryker TPX System
Singapore·CLASS B·Stryker Instruments·Registered August 13, 2020Device 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 description
The TPX System is intended for use with the Consolidated Operating Room Equipment (CORE™) 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.
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 TPX™ Router 1.5 x 12mm TPX™ Router 1.5 x 20mm TPX™ Router 1.5 x 30mm TPX™ Router TPX™ Micro Drill TPX™ Oscillating Saw TPX™ Sagittal Saw TPX™ Reciprocating Saw TPX™ Wiredriver TPX™ Universal Driver TPX™ 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
About this record
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS B