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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 the device name listed in this FDA 510(k) record. The listed applicant is Exactech, Inc.. It received FDA 510(k) clearance on 2023-05-19 under 510(k) 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. The listed applicant is Exactech, Inc.. The 510(k) number is K221323.

When did Exactech® Alteon® Short Tapered Wedge receive FDA 510(k) clearance?

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

Who is the listed applicant for Exactech® Alteon® Short Tapered Wedge?

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 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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