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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 the device name listed in this FDA 510(k) record. The listed applicant is Depuy Ireland UC. It received FDA 510(k) clearance on 2022-10-17 under 510(k) 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. The listed applicant is Depuy Ireland UC. The 510(k) number is K212746.

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

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

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

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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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

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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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