Singapore HSA registration DE0503411
DePuy GLOBAL ICON STEMLESS SHOULDER SYSTEM
Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- Orthopaedics
Registration information
- Registration Number
- DE0503411
- Registration Date
- July 30, 2019
- Change Notification Approval Date
- April 18, 2023
- Retention Due Date
- July 29, 2025
Product description
The DePuy Stemless Shoulder System is indicated for a severely painful and/or arthritic joint (typically due to non-inflammatory degenerative joint disease). The DePuy stemless humeral components are intended for press-fit fixation without the use of bone cement. The glenoid components are intended only for use with bone cement.
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)
- Global Icon Anchor Plate Size 40 HA Global Icon Anchor Plate Size 42 HA Global Icon Anchor Plate Size 44 HA Global Icon Anchor Plate Size 46 HA Global Icon Anchor Plate Size 48 HA Global Icon Anchor Plate Size 50 HA Global Icon Anchor Plate Size 52 HA Global Icon Anchor Plate Size 54 HA Global Icon Anchor Plate Size 56 HA Global Icon Humeral Head Diameter 40mm Global Icon Humeral Head Diameter 42mm Global Icon Humeral Head Diameter 44mm Global Icon Humeral Head Diameter 46mm Global Icon Humeral Head Diameter 48mm Global Icon Humeral Head Diameter 50mm Global Icon Humeral Head Diameter 52mm Global Icon Humeral Head Diameter 54mm Global Icon Humeral Head Diameter 56mm Global Icon Humeral Head Diameter 40mm + 3 Global Icon Humeral Head Diameter 42mm + 3 Global Icon Humeral Head Diameter 44mm + 3 Global Icon Humeral Head Diameter 46mm + 3 Global Icon Humeral Head Diameter 48mm + 3 Global Icon Humeral Head Diameter 50mm + 3 Global Icon Humeral Head Diameter 52mm + 3 Global Icon Humeral Head Diameter 54mm + 3 Global Icon Humeral Head Diameter 56mm + 3 GLOBAL ICON STEMLESS SHOULDER SYSTEM HUMERAL HEAD TRIAL SIZE 40 GLOBAL ICON STEMLESS SHOULDER SYSTEM HUMERAL HEAD TRIAL SIZE 42 GLOBAL ICON STEMLESS SHOULDER SYSTEM HUMERAL HEAD TRIAL SIZE 44 GLOBAL ICON STEMLESS SHOULDER SYSTEM HUMERAL HEAD TRIAL SIZE 46 GLOBAL ICON STEMLESS SHOULDER SYSTEM HUMERAL HEAD TRIAL SIZE 48 GLOBAL ICON STEMLESS SHOULDER SYSTEM HUMERAL HEAD TRIAL SIZE 50 GLOBAL ICON STEMLESS SHOULDER SYSTEM HUMERAL HEAD TRIAL SIZE 52 GLOBAL ICON STEMLESS SHOULDER SYSTEM HUMERAL HEAD TRIAL SIZE 54 GLOBAL ICON STEMLESS SHOULDER SYSTEM HUMERAL HEAD TRIAL SIZE 56 Global Icon Stemless Shoulder System Central Drill GLOBAL ICON STEMLESS SHOULDER SYSTEM HUMERAL HEAD TRIAL DIAMETER 40 +3MM GLOBAL ICON STEMLESS SHOULDER SYSTEM HUMERAL HEAD TRIAL DIAMETER 42 +3MM GLOBAL ICON STEMLESS SHOULDER SYSTEM HUMERAL HEAD TRIAL DIAMETER 44 +3MM GLOBAL ICON STEMLESS SHOULDER SYSTEM HUMERAL HEAD TRIAL DIAMETER 46 +3MM GLOBAL ICON STEMLESS SHOULDER SYSTEM HUMERAL HEAD TRIAL DIAMETER 48 +3MM GLOBAL ICON STEMLESS SHOULDER SYSTEM HUMERAL HEAD TRIAL DIAMETER 50 +3MM GLOBAL ICON STEMLESS SHOULDER SYSTEM HUMERAL HEAD TRIAL DIAMETER 52 +3MM GLOBAL ICON STEMLESS SHOULDER SYSTEM HUMERAL HEAD TRIAL DIAMETER 54 +3MM GLOBAL ICON STEMLESS SHOULDER SYSTEM HUMERAL HEAD TRIAL DIAMETER 56 +3MM
- Model Identifier(s)
- 114010040 114010042 114010044 114010046 114010048 114010050 114010052 114010054 114010056 114020040 114020042 114020044 114020046 114020048 114020050 114020052 114020054 114020056 114020340 114020342 114020344 114020346 114020348 114020350 114020352 114020354 114020356 224020040 224020042 224020044 224020046 224020048 224020050 224020052 224020054 224020056 224020150 224020340 224020342 224020344 224020346 224020348 224020350 224020352 224020354 224020356
About this record
Access comprehensive regulatory information for DePuy GLOBAL ICON STEMLESS SHOULDER 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 DE0503411 and owned by DePuy Ireland UC. The device was registered on July 30, 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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS C