Singapore HSA registration DE0015533
Zimmer® PSI Knee System
Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Orthopaedics
- HSA Product Code
- HSAMDB00111
- HS Code
- 90211000
Registration information
- Registration Number
- DE0015533
- Registration Date
- May 21, 2014
- Retention Due Date
- May 20, 2025
Product description
The Zimmer® PSI Knee System is indicated as an orthopaedic instrument system to assist in the positioning of knee replacement components. It involves surgical planning software used pre-operatively to plan the surgical placement of the components on the basis of provided patient radiological images with identifiable placement anatomical landmarks, and surgical instrument components that include patient specific or customized guides fabricated on the basis of the surgical plan to precisely reference the placement of the implant components intra-operatively per the surgical plan. The Zimmer® PSI Knee System is to be used with the following fixed bearing knee replacement systems in accordance with their indications and contraindications: NexGen CR, NexGen CR-Flex, NexGen CR-Flex Gender, NexGen LPS, NexGen LPS-Flex, NexGen LPS-Flex Gender, Persona CR, and Persona PS. The patient specific guide components are intended for single-use only.
Product Owner
- Name
- Zimmer CAS
- Short Name
- Zimmer CAS
- Address
- 75 Queen Street, Suite 3300, Montreal, Quebec, 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)
- PRI Drop Rod Adaptor Persona Drop Rod Adaptor PSN Jigs ARef L PSN Jigs ARef R PSN Jigs ARef & Tib Rot L PSN Jigs ARef & Tib Rot R NG Legacy Jigs L NG Legacy Jigs R NG Legacy Jigs & Tib Rot L NG Legacy Jigs & Tib Rot R NG Legacy Jigs & Off Tib Rot L NG Legacy Jigs & Off Tib Rot R NG PRI Jigs L NG PRI Jigs R NG PRI Jigs & Tib Rot L NG PRI Jigs & Tib Rot R NG PRI Jigs & Off Tib Rot L NG PRI Jigs & Off Tib Rot R Bone models Software
- Model Identifier(s)
- 20-8014-014-00 20-8014-015-00 20-8070-001-01 20-8070-001-02 20-8070-002-01 20-8070-002-02 20-8070-003-01 20-8070-003-02 20-8070-004-01 20-8070-004-02 20-8070-005-01 20-8070-005-02 20-8070-006-01 20-8070-006-02 20-8070-007-01 20-8070-007-02 20-8070-008-01 20-8070-008-02 20-8070-009-00 803.302
About this record
Access comprehensive regulatory information for Zimmer® PSI 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 DE0015533 and owned by Zimmer CAS. The device was registered on May 21, 2014.
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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