(45 days)
The MedNet LocaTOR, INC., Total Ossicular Replacement Prosthesis (TORP) is to be used by ear, nose and throat physicians to restore the hearing mechanism related to loss or destruction or damage to the ear ossicles due to prolonged chronic infection.
Total Ossicular Replacement Prosthesis (TORP)
This document is a 510(k) clearance letter from the FDA for a Total Ossicular Replacement Prosthesis (TORP). It is a regulatory document, not a study report or a technical performance document. Therefore, it does not contain any of the requested information regarding acceptance criteria, device performance, study details, or ground truth establishment.
The letter primarily states that the device is substantially equivalent to legally marketed predicate devices, allowing its manufacturer, MedNet Locator, Inc., to market it. It also outlines the general regulatory requirements the device must meet.
§ 874.3495 Total ossicular replacement prosthesis.
(a)
Identification. A total ossicular replacement prosthesis is a device intended to be implanted for the total functional reconstruction of the ossicular chain and facilitates the conduction of sound waves from the tympanic membrance to the inner ear. The device is made of materials such as polytetrafluoroethylene, polytetrafluoroethylene with vitreous carbon fibers composite, porous polyethylene, or from a combination of these materials.(b)
Classification. Class II.