Singapore HSA registration DE0504169
Zimmer ROSA Knee System
Singapore·CLASS B·Zimmer CAS·Registered February 26, 2020Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Orthopaedics
Registration information
- Registration Number
- DE0504169
- Registration Date
- February 26, 2020
- Change Notification Approval Date
- December 08, 2022
- Retention Due Date
- February 25, 2026
Product description
The ROSA Knee System is indicated as a stereotaxic instrumentation system for total knee replacement (TKA) surgery. It is to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate placement of knee implant components. The system can also be used to assist in joint balancing techniques. The robotic arm placement is performed relative to anatomical landmarks as recorded using the system intraoperatively, and based on a surgical plan, optionally determined pre-operatively using compatible X-ray or MRI based surgical planning tools.
Product Owner
- Name
- Zimmer CAS
- Short Name
- Zimmer CAS
- Address
- 75 Queen Street, Suite 3300, Montreal, Quebec, H3C 2N6, CANADA
Registrant
- Name
- ZIMMER PTE. LTD.
- Address
- 401 COMMONWEALTH DRIVE, HAW PAR TECHNO CENTRE, #06-03, SINGAPORE 149598
Importer
- Name
- ZIMMER PTE. LTD.
- Address
- 401 COMMONWEALTH DRIVE, HAW PAR TECHNO CENTRE, #06-03, SINGAPORE 149598
Model information
- Model Name(s)
- Fixed Fluted Pin 3.2x150mm Fixed Fluted Pin 3.2x80mm ROSA Persona TKA Cut Guide A ROSA Persona TKA Cut Guide B ROSA NexGen TKA Cut Guide A ROSA NexGen TKA Cut Guide B ROSA Vanguard TKA Cut Guide A ROSA Vanguard TKA Cut Guide B ROSA Registration Pointer ROSA Tibia Reference A ROSA Tibia Reference B ROSA Knee Robotic Unit GB PL G ROSA Recon Robotic Unit 220V ROSA Recon Optical Unit ROSA Knee Software
- Model Identifier(s)
- 20-8000-000-10 20-8000-000-11 20-8020-007-00 20-8020-008-00 20-8020-009-00 20-8020-010-00 20-8020-011-00 20-8020-012-00 20-8020-013-00 20-8020-028-00 20-8020-029-00 20-8020-110-12 20-8020-110-26 20-8020-120-01 20-8020-130-01
About this record
Access comprehensive regulatory information for Zimmer ROSA Knee 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 DE0504169 and owned by Zimmer CAS. The device was registered on February 26, 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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