Brainlab Compatible K2M Navigation Instruments System - HSA Registration DE0509698
Access comprehensive regulatory information for Brainlab Compatible K2M Navigation Instruments System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0509698 and owned by K2M, Inc.. The device was registered on August 28, 2024.
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.
The Brainlab Compatible K2M Navigation Instruments are intended for exclusive use with the Brainlab Navigation System to facilitate the preparation and placement of the pedicle screws when implanting Mesa, Denali, Everest and Yukon spinal systems. Indications for use Brainlab Compatible K2M Navigation Instruments are intended to be used in the preparation and placement of Stryker screws (Mesa, Denali, Everest, and Yukon) during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are specifically designed for use with the Brainlab Navigation System which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.