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FDA 510(k)

DePuy 3D Additive TriFlange Acetabular Cup

K-Number: K201348 · 2022-06-16

ApplicantDepuy International, Ltd.
Decision Date2022-06-16
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DePuy 3D Additive TriFlange Acetabular Cup is a medical device manufactured by Depuy International, Ltd.. It received FDA 510(k) clearance on 2022-06-16 under approval number K201348. 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 DePuy 3D Additive TriFlange Acetabular Cup?

DePuy 3D Additive TriFlange Acetabular Cup is a medical device that received FDA 510(k) clearance on 2022-06-16. It is manufactured by Depuy International, Ltd.. The 510(k) number is K201348.

When was DePuy 3D Additive TriFlange Acetabular Cup approved by the FDA?

DePuy 3D Additive TriFlange Acetabular Cup received FDA 510(k) clearance on 2022-06-16, under approval number K201348.

What company makes DePuy 3D Additive TriFlange Acetabular Cup?

DePuy 3D Additive TriFlange Acetabular Cup is manufactured by Depuy International, Ltd..

What is the FDA product code for DePuy 3D Additive TriFlange Acetabular Cup?

The FDA product code for DePuy 3D Additive TriFlange Acetabular Cup is LPH.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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