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FDA 510(k)

Redemption Duo Hindfoot Nail System

K-Number: K231343 · 2024-01-30

ApplicantVilex, LLC
Decision Date2024-01-30
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Redemption Duo Hindfoot Nail System is a medical device manufactured by Vilex, LLC. It received FDA 510(k) clearance on 2024-01-30 under approval number K231343. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Redemption Duo Hindfoot Nail System?

Redemption Duo Hindfoot Nail System is a medical device that received FDA 510(k) clearance on 2024-01-30. It is manufactured by Vilex, LLC. The 510(k) number is K231343.

When was Redemption Duo Hindfoot Nail System approved by the FDA?

Redemption Duo Hindfoot Nail System received FDA 510(k) clearance on 2024-01-30, under approval number K231343.

What company makes Redemption Duo Hindfoot Nail System?

Redemption Duo Hindfoot Nail System is manufactured by Vilex, LLC.

What is the FDA product code for Redemption Duo Hindfoot Nail System?

The FDA product code for Redemption Duo Hindfoot Nail System is HSB.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.