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FDA 510(k)

REDEMPTION Charcot Plating System

K-Number: K233816 · 2024-08-28

ApplicantVilex, LLC
Decision Date2024-08-28
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

REDEMPTION Charcot Plating System is a medical device manufactured by Vilex, LLC. It received FDA 510(k) clearance on 2024-08-28 under approval number K233816. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REDEMPTION Charcot Plating System?

REDEMPTION Charcot Plating System is a medical device that received FDA 510(k) clearance on 2024-08-28. It is manufactured by Vilex, LLC. The 510(k) number is K233816.

When was REDEMPTION Charcot Plating System approved by the FDA?

REDEMPTION Charcot Plating System received FDA 510(k) clearance on 2024-08-28, under approval number K233816.

What company makes REDEMPTION Charcot Plating System?

REDEMPTION Charcot Plating System is manufactured by Vilex, LLC.

What is the FDA product code for REDEMPTION Charcot Plating System?

The FDA product code for REDEMPTION Charcot Plating System is HRS.

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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.