Singapore HSA registration DE0502691
Biomet Comprehensive Shoulder System Nano Humeral Component
Singapore·CLASS C·Biomet Orthopedics·Registered January 18, 2019Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- Orthopaedics
Registration information
- Registration Number
- DE0502691
- Registration Date
- January 18, 2019
- Change Notification Approval Date
- April 26, 2024
- Retention Due Date
- January 17, 2026
Product description
The Comprehensive Shoulder System with Nano Humeral Component provides the surgeon with a shoulder replacement option for partial, or total joint arthroplasty. 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis 2. Rheumatoid arthritis 3. Revision where other devices or treatments have failed 4. Correction of functional deformity 5. Difficult clinical management problems where other methods of treatment may not be suitable or may be inadequate. The Comprehensive nano Humeral Component is intended only for uncemented biological fixation. The Comprehensive nano Humeral Components are intended for use with the Bio-Modular and Versa-Dial Humeral Heads and the Bio-Modular and Comprehensive glenoid components.
Product Owner
- Short Name
- Biomet Orthopedics
- Address
- 56 East Bell Drive, P.O. Box 587, Warsaw, Indiana, 46581, UNITED STATES
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)
- Comprehensive Shoulder System Nano Steinmann Pin, 7 inch Comprehensive Shoulder System Nano Humeral Component, 30 mm Comprehensive Shoulder System Nano Humeral Component, 32 mm Comprehensive Shoulder System Nano Humeral Component, 34 mm Comprehensive Shoulder System Nano Humeral Component, 36 mm Comprehensive Shoulder System Nano Humeral Component, 38 mm Comprehensive Shoulder System Nano Humeral Component, 40 mm Comprehensive Shoulder System Nano Steinmann Pin, 7 inch
- Model Identifier(s)
- 110045821 115730 115732 115734 115736 115738 115740 31-406990
About this record
Access comprehensive regulatory information for Biomet Comprehensive Shoulder System Nano Humeral Component in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0502691 and owned by Biomet Orthopedics. The device was registered on January 18, 2019.
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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