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DePuy VELYS™ Robotic-Assisted Solution - HSA Registration DE0508421

Access comprehensive regulatory information for DePuy VELYS™ Robotic-Assisted Solution in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0508421 and owned by DePuy Ireland UC. The device was registered on August 22, 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 B
DE0508421
DePuy VELYS™ Robotic-Assisted Solution
HSA Registration Number: DE0508421
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Product Description

The VELYS™ Robotic-Assisted Solution is intended for stereotaxic surgery to help the surgeon to identify the relative position and orientation of anatomical structures, plan the position of the femoral and tibial implant components intraoperatively, and prepare the bones during total knee arthroplasty. The VELYS™ Robotic-Assisted Solution is indicated for use with the ATTUNE™ Total Knee System and its cleared indications for use.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Orthopaedics
Registration Information
Registration Number
DE0508421
Registration Date
August 22, 2023
Change Notification Approval Date
November 25, 2024
Retention Due Date
August 21, 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
Model Information
Model Name(s)
VELYS™ Oscillating Saw Blade 85 mm x 19 mm x 2 mm VELYS™ Array Drill Pin 100 mm x 4 mm VELYS™ Array Drill Pin 125 mm x 4 mm VELYS™ Array Drill Pin 175 mm x 4 mm Puresight™ Array Set - Knee VELYS™ Base Station VELYS™ Satellite Station VELYS™ Saw Handpiece Saw Interface Left Saw Interface Right Array Clamp Device Array Interface
Model Identifier(s)
451570000 451570004 451570005 451570006 451570011 451570100 451570101 451570102 451570105 451570106 451570107 451570109