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FDA 510(k)

ATTUNE® Revision Cones

K-Number: K230295 · 2023-03-10

ApplicantDepuy Ireland UC
Decision Date2023-03-10
Product CodeMBH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ATTUNE® Revision Cones is a medical device manufactured by Depuy Ireland UC. It received FDA 510(k) clearance on 2023-03-10 under approval number K230295. The device is classified under product code MBH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ATTUNE® Revision Cones?

ATTUNE® Revision Cones is a medical device that received FDA 510(k) clearance on 2023-03-10. It is manufactured by Depuy Ireland UC. The 510(k) number is K230295.

When was ATTUNE® Revision Cones approved by the FDA?

ATTUNE® Revision Cones received FDA 510(k) clearance on 2023-03-10, under approval number K230295.

What company makes ATTUNE® Revision Cones?

ATTUNE® Revision Cones is manufactured by Depuy Ireland UC.

What is the FDA product code for ATTUNE® Revision Cones?

The FDA product code for ATTUNE® Revision Cones is MBH.

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

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Related Devices (Code: MBH)

K162256Klassic Femur, Porous, Klassic Tibial Baseplate, PorousTotal Joint Orthopedics, Inc. K153657Vanguard XP Knee SystemBiomet, Inc. K153776Optetrak One Logic Femoral ComponentsExactech, Inc. K153586Arthrex iBalance TKA SystemArthrex, Inc. K172634Triathlon® X3® UHMWPE Tibial Inserts and Patellar ComponentsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics K171365Arthrex Knee SystemsArthrex, Inc.

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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