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FDA 510(k)

Mpact Extension

K-Number: K230011 · 2023-09-20

Decision Date2023-09-20
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Mpact Extension is a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2023-09-20 under approval number K230011. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Mpact Extension?

Mpact Extension is a medical device that received FDA 510(k) clearance on 2023-09-20. It is manufactured by Medacta International S.A.. The 510(k) number is K230011.

When was Mpact Extension approved by the FDA?

Mpact Extension received FDA 510(k) clearance on 2023-09-20, under approval number K230011.

What company makes Mpact Extension?

Mpact Extension is manufactured by Medacta International S.A..

What is the FDA product code for Mpact Extension?

The FDA product code for Mpact Extension is LPH.

Other Devices by Medacta International S.A.

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Related Devices (Code: LPH)

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.