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FDA 510(k)

MyPAO Planning Report

K-Number: K200589 · 2021-02-19

ApplicantMedacta International S.A.
Decision Date2021-02-19
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MyPAO Planning Report 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 2021-02-19 under 510(k) number K200589. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MyPAO Planning Report?

MyPAO Planning Report is a medical device that received FDA 510(k) clearance on 2021-02-19. The listed applicant is Medacta International S.A.. The 510(k) number is K200589.

When did MyPAO Planning Report receive FDA 510(k) clearance?

MyPAO Planning Report received FDA 510(k) clearance on 2021-02-19, under 510(k) number K200589.

Who is the listed applicant for MyPAO Planning Report?

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 MyPAO Planning Report?

The FDA product code for MyPAO Planning Report is LLZ.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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