OR3O Dual Mobility Liners
K-Number: K232667 · 2023-10-27
ApplicantSmith & Nephew, Inc.
Decision Date2023-10-27
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
OR3O Dual Mobility Liners is a medical device manufactured by Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2023-10-27 under approval number K232667. 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 Liners?
OR3O Dual Mobility Liners is a medical device that received FDA 510(k) clearance on 2023-10-27. It is manufactured by Smith & Nephew, Inc.. The 510(k) number is K232667.
When was OR3O Dual Mobility Liners approved by the FDA?
OR3O Dual Mobility Liners received FDA 510(k) clearance on 2023-10-27, under approval number K232667.
What company makes OR3O Dual Mobility Liners?
OR3O Dual Mobility Liners is manufactured by Smith & Nephew, Inc..
What is the FDA product code for OR3O Dual Mobility Liners?
The FDA product code for OR3O Dual Mobility Liners 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.