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FDA 510(k)

OR3O Dual Mobility System

K-Number: K191002 · 2019-10-31

ApplicantSmith & Nephew, Inc.
Decision Date2019-10-31
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OR3O Dual Mobility System is a medical device manufactured by Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2019-10-31 under approval number K191002. 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 OR3O Dual Mobility System?

OR3O Dual Mobility System is a medical device that received FDA 510(k) clearance on 2019-10-31. It is manufactured by Smith & Nephew, Inc.. The 510(k) number is K191002.

When was OR3O Dual Mobility System approved by the FDA?

OR3O Dual Mobility System received FDA 510(k) clearance on 2019-10-31, under approval number K191002.

What company makes OR3O Dual Mobility System?

OR3O Dual Mobility System is manufactured by Smith & Nephew, Inc..

What is the FDA product code for OR3O Dual Mobility System?

The FDA product code for OR3O Dual Mobility System is LPH.

Related Clinical Trials

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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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