Singapore HSA registration DE0013675
Zimmer iASSIST™ Knee System
Singapore·CLASS B·Zimmer CAS·Registered August 23, 2013Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Orthopaedics
Registration information
- Registration Number
- DE0013675
- Registration Date
- August 23, 2013
- Change Notification Approval Date
- November 30, 2023
- Retention Due Date
- August 22, 2025
Product description
The iASSIST™ Knee System is a computer assisted stereotaxic surgical instrument system to assist the surgeon in the positioning of orthopaedic implant system components intra-operatively. It involves surgical instruments and position sensors to determine alignment axes in relation to anatomical landmarks and to precisely position alignment instruments and implant components relative to these axes. Example orthopaedic surgical procedures include but are not limited to: Total Knee Arthroplasty.
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)
- iASSIST Knee System - 3.2mm Headless Trocar drill pin x 1 iASSIST Knee System - 3.5mm Hex head screw x 38mm iASSIST Knee System - CAS Small spike 7.9 mm iASSIST Knee System - Tibial Alignment Guide iASSIST Knee System - Tibial LEFT Adjustment Mechanism iASSIST Knee System - Tibial RIGHT Adjustment Mechanism iASSIST Knee System - Tibial LEFT Cut Guide iASSIST Knee System - Tibial RIGHT Cut Guide iASSIST Knee System - Validation Tool iASSIST Knee System - Alignment Arch iASSIST Knee System - Femoral Adjustment Mechanism iASSIST Knee System - Femoral Reference iASSIST Knee System - Femoral Distal Cut Guide iASSIST Knee System - Femoral AP Slider iASSIST Knee System - Tibial LEFT Positioner iASSIST Knee System - Tibial RIGHT Positioner iASSIST Knee System - Femoral Saw Slot iASSIST Knee System - Pod Calibration Jig iASSIST Knee System - 3.5mm Hex Head Knob Femoral Spike Tibila Aligner - Upper Assembly Tibial Aligner - Lower Assembly iASSIST System Controller Assembly includes the following: iASSIST Knee System - System Controller Computer iASSIST Knee System - System Controller Power Supply iASSIST V2 Tablet iASSIST V2 Tablet Kit iASSIST Knee System V2 Pod Kit iASSIST Knee System V2 Pin and Screw Pack Upper Tibial Reference Lower Tibial Reference Tibial Adjustment Mechanism Tibial Proximal Cut Guide Left Persona/NexGen Tibial Saw Slot Right Persona/NexGen Tibial Saw Slot Left Vanguard Tibial Saw Slot Right Vanguard Tibial Saw Slot Left Tibia A/P Slider Right Tibia A/P Slider Vanguard Femoral Saw Slot iASSIST Knee System V.2.0 Clinical Application iASSIST Knee System V.4.0 Operating System iASSIST Knee Master Instrument Kit includes the folowing:
- Model Identifier(s)
- 20-8000-000-16 20-8000-000-18 20-8000-010-27 20-8011-013-00 20-8011-017-00 20-8011-018-00 20-8011-019-00 20-8011-020-00 20-8011-021-00 20-8011-022-00 20-8011-025-00 20-8011-026-00 20-8011-027-00 20-8011-028-00 20-8011-040-00 20-8011-041-00 20-8011-042-00 20-8011-048-00 20-8011-050-00 20-8011-051-00 20-8011-056-51 20-8011-056-52 20-8011-070-00 20-8011-070-01 20-8011-070-02 20-8011-070-19 20-8011-070-24 20-8011-501-00 20-8011-505-00 20-8011-509-00 20-8011-510-00 20-8011-511-00 20-8011-513-00 20-8011-514-00 20-8011-515-00 20-8011-516-00 20-8011-517-00 20-8011-520-00 20-8011-521-00 20-8011-542-00 20-8011-900-13 302.4021 KT-8011-010-01
About this record
Access comprehensive regulatory information for Zimmer iASSIST™ 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 DE0013675 and owned by Zimmer CAS. The device was registered on August 23, 2013.
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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