(84 days)
The Talus of Vilex, as designed, has the following Indications of Use: Flat foot, pronated subtalar joint.
The material used to manufacture this device is implant-quality titaniumTl6A4V alloy. The device is intended to remain implanted for a finite period of time. The implant is best device is ifitended to remain implanted for a minto for a minto for single use only.
Prescription Use (Per 21 CFR 801.109)
The material used to manufacture this device is implant-quality titaniumTl6A4V alloy. The device is intended to remain implanted for a finite period of time. The implant is best device is ifitended to remain implanted for a minto for a minto for single use only.
This is a 510(k) premarket notification for a medical device called "Talus of Vilex (TOV) Implant". A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. This document does not contain information about the device's acceptance criteria or a study proving its performance against such criteria. It is an FDA clearance letter and an "Indications for Use" statement, outlining the device's intended applications and regulatory classification.
Therefore, I cannot provide the requested information based on the given context.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.