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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.

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