HSA · registration DE0509989

Synthes Tibial Nail Advanced System

Name: Synthes Tibial Nail Advanced System — HSA DE0509989
Creator: Synthes GmbH
Keywords: Synthes Tibial Nail Advanced System, Synthes Tibial Nail Advanced System, DE0509989, Orthopaedics, HSA

SingaporeOrthopaedicsClass CSynthes GmbH

Verified

Official record identity

Registration number: DE0509989
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Registration date: October 29, 2024
Source update date: March 25, 2026

Classification

Risk class: Class C
Published category: Orthopaedics

Published parties

Product owner: Synthes GmbH
Registrant / registration holder: JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE. LTD.

Official description

The Tibial Nail Advanced implants are intended to be used for temporary fixation and stabilization of tibia. The Tibial Nail Advanced implants are intended for treatment of fractures in adults and adolescents (12–21) in which the growth plates have fused. The implants are indicated for: –Open and closed proximal and distal tibial fractures –Open and closed tibial shaft fractures –Tibial malunions and nonunions.

Additional source fields

Product owner address: Eimattstrasse 3, CH-4436 Oberdorf, Switzerland
Registrant address: 2 SCIENCE PARK DRIVE, #07-13, ASCENT, Singapore 118222

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.