Singapore HSA registration DE0508394
DePuy Ireland UC ATTUNE Total Knee System
Singapore·CLASS C·DePuy Ireland UC·Registered August 16, 2023Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- Orthopaedics
Registration information
- Registration Number
- DE0508394
- Registration Date
- August 16, 2023
- Change Notification Approval Date
- March 11, 2024
- Retention Due Date
- August 15, 2025
Product description
ATTUNE® Revision Knee implants are designed for use in total knee arthroplasty for patients with: • Absence or loss of both cruciate ligaments • Moderate varus-valgus or flexion instability that requires a bearing surface with increased constraint in the clinical judgment of the surgeon •Bone loss that requires supplemental fixation in the clinical judgment of the surgeon.
Product Owner
- Name
- DePuy Ireland UC
- Short Name
- DePuy Ireland UC
- Address
- Loughbeg, Ringaskiddy, Co. Cork, Ireland, IRELAND
Registrant
- Address
- 2 SCIENCE PARK DRIVE, ASCENT, #07-13, SINGAPORE 118222
Importer
- Address
- 2 SCIENCE PARK DRIVE, ASCENT, #07-13, SINGAPORE 118222 2 SCIENCE PARK DRIVE, ASCENT, #07-13, SINGAPORE 118222
Model information
- Model Name(s)
- ATTUNE Revision Tibial Base Fixed Bearing Size 1 Cemented ATTUNE Revision Tibial Base Fixed Bearing Size 2 Cemented ATTUNE Revision Tibial Base Fixed Bearing Size 3 Cemented ATTUNE Revision Tibial Base Fixed Bearing Size 4 Cemented ATTUNE Revision Tibial Base Fixed Bearing Size 5 Cemented ATTUNE Revision Tibial Base Fixed Bearing Size 6 Cemented ATTUNE Revision Tibial Base Fixed Bearing Size 7 Cemented ATTUNE Revision Tibial Base Fixed Bearing Size 8 Cemented ATTUNE Revision Tibial Base Fixed Bearing Size 9 Cemented ATTUNE Revision Tibial Base Fixed Bearing Size 10 Cemented
- Model Identifier(s)
- 150640001 150640002 150640003 150640004 150640005 150640006 150640007 150640008 150640009 150640010
About this record
Access comprehensive regulatory information for DePuy Ireland UC ATTUNE Total Knee System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0508394 and owned by DePuy Ireland UC. The device was registered on August 16, 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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS C