Singapore HSA registration DE0508108
Wright Medical PROPHECY™ INFINITY™ Pre-Operative Navigation Alignment Guides
Singapore·CLASS B·Wright Medical Technology Inc.·Registered May 19, 2023Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Orthopaedics
Registration information
- Registration Number
- DE0508108
- Registration Date
- May 19, 2023
- Retention Due Date
- May 18, 2025
Product description
Prophecy Surgical Planning is intended to be used as patient specific surgical instrumentation to assist in the positioning of total ankle replacement components intraoperatively, in guiding the marking of bone before cutting, and in the pre-surgical planning of the ankle and surrounding anatomy to support the total ankle implant. The Prophecy Surgical Planning Guides and Reports are intended for use with the Inbone®, Infinity® and Invision® Total Ankle Systems and their cleared indications for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. The Prophecy Surgical Planning Guides are intended for single use only.
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)
- PROPHECY INFINITY PATIENT SPECIFIC GUIDES (length: maximum 5", width: maximum 5") PROPHECY PATIENT SPECIFIC GUIDES FOR INFINITY WITH FOOTPRINT (length: maximum 5", width: maximum 5")
- Model Identifier(s)
- PROPINF (length, width) PROPINFF (length, width)
About this record
Access comprehensive regulatory information for Wright Medical PROPHECY™ INFINITY™ Pre-Operative Navigation Alignment Guides in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0508108 and owned by Wright Medical Technology Inc.. The device was registered on May 19, 2023.
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS B