HSA · registration DE0510656

Smith & Nephew ULTRABRACE Kit

Name: Smith & Nephew ULTRABRACE Kit — HSA DE0510656
Creator: Smith & Nephew Inc. Endoscopy
Keywords: Smith & Nephew ULTRABRACE Kit, Smith & Nephew ULTRABRACE Kit, DE0510656, Orthopaedics, HSA

SingaporeOrthopaedicsClass CSmith & Nephew Inc. Endoscopy

Verified

Official record identity

Registration number: DE0510656
Model name: ULTRABRACE KIT; FOOTPRINT MINI PK 3.5MM; FOOTPRINT MINI DRILL 3.5MM; Q-FIX ULTRA; Q-FIX ULTRA CANNULATED DRILL, 2.9MM & 1.25MM DRILL PIN; EXTREMITIES GUIDE UNIVERSAL; FOOTPRINT MINI DRILL 3.7MM
Model identifier: 72205500; 72205687; 72205688; 72205693; 72205694; 72205699; 72205888
Registration date: April 30, 2025

Classification

Risk class: Class C
Published category: Orthopaedics

Published parties

Product owner: Smith & Nephew Inc. Endoscopy
Registrant / registration holder: SMITH & NEPHEW PTE. LIMITED

Official description

The ULTRABRACE™ Kit is only intended for the reattachment of soft tissue to bone for the following indications: Foot and Ankle • Medial or lateral instability repairs/reconstructions

Additional source fields

Product owner address: 150 Minuteman Road, Andover, Massachusetts, 01810, United States
Registrant address: 29 MEDIA CIRCLE, #06-05, ALICE@MEDIAPOLIS, Singapore 138565

About this record

This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.