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DePuy Ireland UC ATTUNE Total Knee System - HSA Registration DE0508394

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.

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CLASS C
DE0508394
DePuy Ireland UC ATTUNE Total Knee System
HSA Registration Number: DE0508394
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Product Description

ATTUNEยฎ Revision Knee implants are designed for use in total knee arthroplasty for patients with: โ€ข Absence or loss of both cruciate ligaments โ€ข Moderate varus-valgus or flexion instability that requires a bearing surface with increased constraint in the clinical judgment of the surgeon โ€ขBone loss that requires supplemental fixation in the clinical judgment of the surgeon.

Device 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 Owner
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