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FDA 510(k)

ATTUNE Revision Cones

K-Number: K212746 · 2022-10-17

ApplicantDepuy Ireland UC
Decision Date2022-10-17
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 2022-10-17 under approval number K212746. 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 2022-10-17. It is manufactured by Depuy Ireland UC. The 510(k) number is K212746.

When was ATTUNE Revision Cones approved by the FDA?

ATTUNE Revision Cones received FDA 510(k) clearance on 2022-10-17, under approval number K212746.

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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