Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Advanced MyHip Planner

K-Number: K221725 · 2023-01-20

Decision Date2023-01-20
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Advanced MyHip Planner 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 2023-01-20 under 510(k) number K221725. 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 Advanced MyHip Planner?

Advanced MyHip Planner is a medical device that received FDA 510(k) clearance on 2023-01-20. The listed applicant is Medacta International S.A.. The 510(k) number is K221725.

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

Advanced MyHip Planner received FDA 510(k) clearance on 2023-01-20, under 510(k) number K221725.

Who is the listed applicant for Advanced MyHip Planner?

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 Advanced MyHip Planner?

The FDA product code for Advanced MyHip Planner is LLZ.

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.

View all 146 devices →

Related Devices (Code: LLZ)

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.

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.