HSA · registration DE0509864

Smith & Nephew ULTRABUTTON Adjustable Fixation Devices

Name: Smith & Nephew ULTRABUTTON Adjustable Fixation Devices — HSA DE0509864
Creator: Smith & Nephew Inc.
Keywords: Smith & Nephew ULTRABUTTON Adjustable Fixation Devices, Smith & Nephew ULTRABUTTON Adjustable Fixation Devices, DE0509864, Orthopaedics, HSA

SingaporeOrthopaedicsClass CSmith & Nephew Inc.

Verified

Official record identity

Registration number: DE0509864
Model name: 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: 72205443; 72205444; 72205600; 72205601; 72205602
Registration date: October 01, 2024

Classification

Risk class: Class C
Published category: Orthopaedics

Published parties

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

Official 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.

Additional source fields

Product owner address: 150 Minuteman Road, Andover, Massachusetts, 01810-1031, 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.