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FDA 510(k)

Attune Revision LPS Inserts

K-Number: K191779 · 2019-10-08

ApplicantDepuy(Ireland)
Decision Date2019-10-08
Product CodeKRO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Attune Revision LPS Inserts is a medical device manufactured by Depuy(Ireland). It received FDA 510(k) clearance on 2019-10-08 under approval number K191779. The device is classified under product code KRO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Attune Revision LPS Inserts?

Attune Revision LPS Inserts is a medical device that received FDA 510(k) clearance on 2019-10-08. It is manufactured by Depuy(Ireland). The 510(k) number is K191779.

When was Attune Revision LPS Inserts approved by the FDA?

Attune Revision LPS Inserts received FDA 510(k) clearance on 2019-10-08, under approval number K191779.

What company makes Attune Revision LPS Inserts?

Attune Revision LPS Inserts is manufactured by Depuy(Ireland).

What is the FDA product code for Attune Revision LPS Inserts?

The FDA product code for Attune Revision LPS Inserts is KRO.

Related Clinical Trials

NCT03153449 ATTUNE® Revision- Complex Primary in Total Knee Arthroplasty Population ACTIVE_NOT_RECRUITING NCT03153475 ATTUNE Revision System in the Revision Total Knee Arthroplasty Population ACTIVE_NOT_RECRUITING

Other Devices by Depuy(Ireland)

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Related Devices (Code: KRO)

K163311GMK Revision Femoral Distal AugmentationMedacta International S.A. K161520ELEOS Limb Salvage SystemOnkos Surgical, Inc. K152431LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx (TiNbN) coatingWaldemar Link GmbH & Co. KG K172347GMK Hinge, GMK RevisionMedacta International S.A. K190181Instruments for LINK MEGASYSTEM-C FamilyLinkBio Corp. K190100USTAR II SystemUnited Orthopedic Corporation

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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