Singapore HSA registration DE0503429
Wright Medical PRO-TOE C2 Hammertoe Fixation System
Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- Orthopaedics
Registration information
- Registration Number
- DE0503429
- Registration Date
- August 02, 2019
- Change Notification Approval Date
- November 18, 2022
- Retention Due Date
- August 01, 2025
Product description
The PRO-TOETM Hammertoe Fixation Systems are indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe. Cannulated Implants in the PRO-TOETM Hammertoe Fixation Systems, with the exception of the PRO-TOETM X-FLEX, can be used with K-wires for the delivery of implants or the temporary stabilization of outlying joints (e.g. MTP Joint). The Implantable K-Wires are indicated for use in fixation of bone fractures, for bone reconstructions, and as guide pins for insertion of other implants. Additionally, Implantable K-Wires are indicated for the fixation of osteotomies and reconstruction of the lesser toe following correction procedures for hammertoe, claw toe, mallet toe, and metatarsophalangeal joint instability.
Product Owner
- Short Name
- Wright Medical Technology Inc.
- Address
- 1023 Cherry Road, Memphis, TN 38117, UNITED STATES
Registrant
- Address
- 1 GEORGE STREET, ONE GEORGE STREET, #20-1/2/3, SINGAPORE 049145
Importer
- Address
- 47 JALAN BUROH, #09-01, SINGAPORE 619491 1 GEORGE STREET, ONE GEORGE STREET, #20-1/2/3, SINGAPORE 049145
Model information
- Model Name(s)
- K-WIRE w/Double Trocar K-WIRE w/Double Trocar PRO-TOE C2 Implant PRO-TOE C2 Compression Implant PRO-TOE C2 Compression Implant PRO-TOE C2 Compression Implant PRO-TOE C2 Compression Implant PRO-TOE C2 Compression Implant
- Model Identifier(s)
- 45750001 45750003 45802013 45802413 45803013 45803016 45803513 45803516
About this record
Access comprehensive regulatory information for Wright Medical PRO-TOE C2 Hammertoe Fixation System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0503429 and owned by Wright Medical Technology Inc.. The device was registered on August 02, 2019.
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.
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