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FDA 510(k)

MyHip Planner & Verifier

K-Number: K200350 · 2020-11-04

ApplicantMedacta International S.A.
Decision Date2020-11-04
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MyHip Planner & Verifier 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 2020-11-04 under 510(k) number K200350. 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 MyHip Planner & Verifier?

MyHip Planner & Verifier is a medical device that received FDA 510(k) clearance on 2020-11-04. The listed applicant is Medacta International S.A.. The 510(k) number is K200350.

When did MyHip Planner & Verifier receive FDA 510(k) clearance?

MyHip Planner & Verifier received FDA 510(k) clearance on 2020-11-04, under 510(k) number K200350.

Who is the listed applicant for MyHip Planner & Verifier?

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 MyHip Planner & Verifier?

The FDA product code for MyHip Planner & Verifier is LLZ.

Other records listing Medacta International S.A. as applicant

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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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