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FDA 510(k)

EMPHASYS™ Dual Mobility System

K-Number: K231522 · 2024-02-15

ApplicantDepuy Ireland UC
Decision Date2024-02-15
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EMPHASYS™ Dual Mobility System 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 2024-02-15 under 510(k) number K231522. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMPHASYS™ Dual Mobility System?

EMPHASYS™ Dual Mobility System is a medical device that received FDA 510(k) clearance on 2024-02-15. The listed applicant is Depuy Ireland UC. The 510(k) number is K231522.

When did EMPHASYS™ Dual Mobility System receive FDA 510(k) clearance?

EMPHASYS™ Dual Mobility System received FDA 510(k) clearance on 2024-02-15, under 510(k) number K231522.

Who is the listed applicant for EMPHASYS™ Dual Mobility System?

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 EMPHASYS™ Dual Mobility System?

The FDA product code for EMPHASYS™ Dual Mobility System is LPH.

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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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