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FDA 510(k)

ARTICUL/EZE Ceramic Heads

K-Number: K222296 · 2023-01-06

ApplicantDepuy Ireland UC
Decision Date2023-01-06
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ARTICUL/EZE Ceramic Heads is the device name listed in this FDA 510(k) record. The listed applicant is Depuy Ireland UC. It received FDA 510(k) clearance on 2023-01-06 under 510(k) number K222296. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARTICUL/EZE Ceramic Heads?

ARTICUL/EZE Ceramic Heads is a medical device that received FDA 510(k) clearance on 2023-01-06. The listed applicant is Depuy Ireland UC. The 510(k) number is K222296.

When did ARTICUL/EZE Ceramic Heads receive FDA 510(k) clearance?

ARTICUL/EZE Ceramic Heads received FDA 510(k) clearance on 2023-01-06, under 510(k) number K222296.

Who is the listed applicant for ARTICUL/EZE Ceramic Heads?

The FDA 510(k) record lists Depuy Ireland UC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARTICUL/EZE Ceramic Heads?

The FDA product code for ARTICUL/EZE Ceramic Heads is LZO.

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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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