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FDA 510(k)

Alteon® HA Femoral Stems

K-Number: K243839 · 2025-03-10

ApplicantExactech, Inc.
Decision Date2025-03-10
Product CodeMEH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Alteon® HA Femoral Stems is the device name listed in this FDA 510(k) record. The listed applicant is Exactech, Inc.. It received FDA 510(k) clearance on 2025-03-10 under 510(k) number K243839. The device is classified under product code MEH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Alteon® HA Femoral Stems?

Alteon® HA Femoral Stems is a medical device that received FDA 510(k) clearance on 2025-03-10. The listed applicant is Exactech, Inc.. The 510(k) number is K243839.

When did Alteon® HA Femoral Stems receive FDA 510(k) clearance?

Alteon® HA Femoral Stems received FDA 510(k) clearance on 2025-03-10, under 510(k) number K243839.

Who is the listed applicant for Alteon® HA Femoral Stems?

The FDA 510(k) record lists Exactech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Alteon® HA Femoral Stems?

The FDA product code for Alteon® HA Femoral Stems is MEH.

Other records listing Exactech, Inc. as applicant

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Related Devices (Code: MEH)

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.

K261576Icona Hip StemCorin, Ltd.K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KGK251166Mfinity Femoral SystemMedacta International S.A.K251052Trivicta® Hip StemOrtho Development Corp.K242315Resolve Modular Revision Hip StemUnited Orthopedic CorporationK243162World LinerSignature Orthopaedics Pty, Ltd.

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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