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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 the device name listed in this FDA 510(k) record. The listed applicant is Depuy Ireland UC. It received FDA 510(k) clearance on 2023-03-10 under 510(k) 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. The listed applicant is Depuy Ireland UC. The 510(k) number is K230295.

When did ATTUNE® Revision Cones receive FDA 510(k) clearance?

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

Who is the listed applicant for ATTUNE® Revision Cones?

The FDA 510(k) record lists Depuy Ireland UC as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Depuy Ireland UC as applicant

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Related Devices (Code: MBH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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