FDA 510(k)

Humeral Eccentric Reverse Metaphysis

K-Number: K210207 · 2021-03-26

Decision Date2021-03-26

Product CodePHX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Humeral Eccentric Reverse Metaphysis 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 2021-03-26 under 510(k) number K210207. The device is classified under product code PHX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Humeral Eccentric Reverse Metaphysis?

Humeral Eccentric Reverse Metaphysis is a medical device that received FDA 510(k) clearance on 2021-03-26. The listed applicant is Medacta International S.A.. The 510(k) number is K210207.

When did Humeral Eccentric Reverse Metaphysis receive FDA 510(k) clearance?

Humeral Eccentric Reverse Metaphysis received FDA 510(k) clearance on 2021-03-26, under 510(k) number K210207.

Who is the listed applicant for Humeral Eccentric Reverse Metaphysis?

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 Humeral Eccentric Reverse Metaphysis?

The FDA product code for Humeral Eccentric Reverse Metaphysis is PHX.

Other records listing Medacta International S.A. as applicant

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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.