Singapore HSA registration DE0508780
ONE Planner™ Hip
Singapore·CLASS B·Zimmer CAS·Registered December 21, 2023Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Orthopaedics
Registration information
- Registration Number
- DE0508780
- Registration Date
- December 21, 2023
- Retention Due Date
- December 20, 2025
Product description
ONE Planner™ Hip (OPH) is an interactive software application intended to be used as a preoperative tool for Total Hip Arthroplasty. It enables 2D sizing and positioning of implants in the patient’s anatomy, calculates biomechanical measurements and performs functional analysis based on the patient’s pelvic kinematics. The biomechanical measurements include measurements related to leg length and femoral offset. The functional analysis includes determination of pelvic parameters (e.g. pelvic tilt), and cup orientation calculations. The software application consists of an automated templating system and a web-based templating user interface.
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)
- ONE Planner™ Hip
- Model Identifier(s)
- CG200
About this record
Access comprehensive regulatory information for ONE Planner™ Hip in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0508780 and owned by Zimmer CAS. The device was registered on December 21, 2023.
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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