Wright Medical PROPHECY™ INFINITY™ Pre-Operative Navigation Alignment Guides - HSA Registration DE0508108
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.
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.