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FDA 510(k)

ALPHALOK Plating System

K-Number: K221558 · 2022-11-15

ApplicantVilex, LLC
Decision Date2022-11-15
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ALPHALOK Plating System is a medical device manufactured by Vilex, LLC. It received FDA 510(k) clearance on 2022-11-15 under approval number K221558. 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 ALPHALOK Plating System?

ALPHALOK Plating System is a medical device that received FDA 510(k) clearance on 2022-11-15. It is manufactured by Vilex, LLC. The 510(k) number is K221558.

When was ALPHALOK Plating System approved by the FDA?

ALPHALOK Plating System received FDA 510(k) clearance on 2022-11-15, under approval number K221558.

What company makes ALPHALOK Plating System?

ALPHALOK Plating System is manufactured by Vilex, LLC.

What is the FDA product code for ALPHALOK Plating System?

The FDA product code for ALPHALOK 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.