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HSA · registration DE0510462

Smith & Nephew Q-FIX with Needles

SingaporeOrthopaedicsClass CSmith & Nephew Inc. Endoscopy
Official record identity
Registration number
DE0510462
Model name
Q-FIX WITH NEEDLES #0 SUTURE; DRILL FOR Q-FIX WITH NEEDLES; Q-FIX WITH NEEDLES MINITAPE
Model identifier
72205691; 72205692; 72205695
Registration date
March 13, 2025
Classification
Risk class
Class C
Official value: CLASS C
Published category
Orthopaedics
Published parties
Registrant / registration holder
SMITH & NEPHEW PTE. LIMITED
Official description

The Q-FIX All-Suture Anchor with Needles use is only intended for the reattachment of soft tissue to bone for the following indications: Foot and Ankle • Medial or lateral instability repairs/reconstructions • Achilles tendon 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.