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 the device name listed in this FDA 510(k) record. The listed applicant is Medacta International S.A.. It received FDA 510(k) clearance on 2023-09-20 under 510(k) 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. The listed applicant is Medacta International S.A.. The 510(k) number is K230011.

When did Mpact Extension receive FDA 510(k) clearance?

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

Who is the listed applicant for Mpact Extension?

The FDA 510(k) record lists Medacta International S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Mpact Extension?

The FDA product code for Mpact Extension is LPH.

Other records listing Medacta International S.A. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.