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Singapore HSA registration DE0509864

Smith & Nephew ULTRABUTTON Adjustable Fixation Devices

Singapore flagSingapore·CLASS C·Smith & Nephew Inc.·Registered October 01, 2024
Device classification
Device Class
CLASS C
Medical Speciality Area
Orthopaedics
Registration information
Registration Number
DE0509864
Registration Date
October 01, 2024
Retention Due Date
September 30, 2025
Product description
The ULTRABUTTON™ QUAD, BB, and TIB Adjustable Fixation Devices are intended for soft tissue to bone or bone-tendon to bone fixation. They are indicated for soft tissue to bone or bone-tendon to bone fixation for: ACL/PCL Repair/Reconstruction and soft tissue to bone fixation for Extracapsular Repair: MCL, LCL.
Product Owner
Name
Smith & Nephew Inc.
Short Name
Smith & Nephew Inc.
Address
150 Minuteman Road, Andover, Massachusetts, 01810-1031, UNITED STATES
Registrant
Name
SMITH & NEPHEW PTE. LIMITED
Address
29 MEDIA CIRCLE, ALICE@MEDIAPOLIS, #06-05, SINGAPORE 138565
Importer
Name
SMITH & NEPHEW ASIA PACIFIC PTE. LIMITED SMITH & NEPHEW PTE. LIMITED
Address
29 MEDIA CIRCLE, ALICE@MEDIAPOLIS, #06-05, SINGAPORE 138565 29 MEDIA CIRCLE, ALICE@MEDIAPOLIS, #06-05, SINGAPORE 138565
Model information
Model Name(s)
ULTRABUTTON QUAD ADJUSTABLE FIXATION DEVICE ULTRABUTTON BB ADJUSTABLE FIXATION DEVICE ULTRABUTTON TIB ADJUSTABLE FIXATION DEVICE, SMALL ULTRABUTTON TIB ADJUSTABLE FIXATION DEVICE, MEDIUM ULTRABUTTON TIB ADJUSTABLE FIXATION DEVICE, LARGE
Model Identifier(s)
72205443 72205444 72205600 72205601 72205602
About this record

Access comprehensive regulatory information for Smith & Nephew ULTRABUTTON Adjustable Fixation Devices in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0509864 and owned by Smith & Nephew Inc.. The device was registered on October 01, 2024.

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