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FDA 510(k)

Exactech® Alteon® Short Tapered Wedge

K-Number: K221323 · 2023-05-19

ApplicantExactech, Inc.
Decision Date2023-05-19
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Exactech® Alteon® Short Tapered Wedge is a medical device manufactured by Exactech, Inc.. It received FDA 510(k) clearance on 2023-05-19 under approval number K221323. 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® Short Tapered Wedge?

Exactech® Alteon® Short Tapered Wedge is a medical device that received FDA 510(k) clearance on 2023-05-19. It is manufactured by Exactech, Inc.. The 510(k) number is K221323.

When was Exactech® Alteon® Short Tapered Wedge approved by the FDA?

Exactech® Alteon® Short Tapered Wedge received FDA 510(k) clearance on 2023-05-19, under approval number K221323.

What company makes Exactech® Alteon® Short Tapered Wedge?

Exactech® Alteon® Short Tapered Wedge is manufactured by Exactech, Inc..

What is the FDA product code for Exactech® Alteon® Short Tapered Wedge?

The FDA product code for Exactech® Alteon® Short Tapered Wedge is LZO.

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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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