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 a medical device manufactured by Exactech, Inc.. It received FDA 510(k) clearance on 2025-03-10 under approval 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. It is manufactured by Exactech, Inc.. The 510(k) number is K243839.
When was Alteon® HA Femoral Stems approved by the FDA?
Alteon® HA Femoral Stems received FDA 510(k) clearance on 2025-03-10, under approval number K243839.
What company makes Alteon® HA Femoral Stems?
Alteon® HA Femoral Stems is manufactured by Exactech, Inc..
What is the FDA product code for Alteon® HA Femoral Stems?
The FDA product code for Alteon® HA Femoral Stems is MEH.
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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.