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FDA 510(k)

Exactech Alteon Highly Polished Femoral Stem

K-Number: K182462 · 2018-11-08

ApplicantExactech, Inc.
Decision Date2018-11-08
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Exactech Alteon Highly Polished Femoral Stem is a medical device manufactured by Exactech, Inc.. It received FDA 510(k) clearance on 2018-11-08 under approval number K182462. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Exactech Alteon Highly Polished Femoral Stem?

Exactech Alteon Highly Polished Femoral Stem is a medical device that received FDA 510(k) clearance on 2018-11-08. It is manufactured by Exactech, Inc.. The 510(k) number is K182462.

When was Exactech Alteon Highly Polished Femoral Stem approved by the FDA?

Exactech Alteon Highly Polished Femoral Stem received FDA 510(k) clearance on 2018-11-08, under approval number K182462.

What company makes Exactech Alteon Highly Polished Femoral Stem?

Exactech Alteon Highly Polished Femoral Stem is manufactured by Exactech, Inc..

What is the FDA product code for Exactech Alteon Highly Polished Femoral Stem?

The FDA product code for Exactech Alteon Highly Polished Femoral Stem is LZO.

Other Devices by Exactech, Inc.

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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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