FDA 510(k)

EMPHASYS Dual Mobility System

K-Number: K231522 · 2024-02-15

Decision Date2024-02-15

Product CodeLPH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

EMPHASYS Dual Mobility System is a medical device manufactured by Depuy Ireland UC. It received FDA 510(k) clearance on 2024-02-15 under approval 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. It is manufactured by Depuy Ireland UC. The 510(k) number is K231522.

When was EMPHASYS Dual Mobility System approved by the FDA?

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

What company makes EMPHASYS Dual Mobility System?

EMPHASYS Dual Mobility System is manufactured by Depuy Ireland UC.

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.