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FDA 510(k)

Exactech Alteon Monobloc Revision Stem

K-Number: K181532 · 2018-09-04

ApplicantExactech, Inc.
Decision Date2018-09-04
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Exactech Alteon Monobloc Revision Stem is the device name listed in this FDA 510(k) record. The listed applicant is Exactech, Inc.. It received FDA 510(k) clearance on 2018-09-04 under 510(k) number K181532. 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 Monobloc Revision Stem?

Exactech Alteon Monobloc Revision Stem is a medical device that received FDA 510(k) clearance on 2018-09-04. The listed applicant is Exactech, Inc.. The 510(k) number is K181532.

When did Exactech Alteon Monobloc Revision Stem receive FDA 510(k) clearance?

Exactech Alteon Monobloc Revision Stem received FDA 510(k) clearance on 2018-09-04, under 510(k) number K181532.

Who is the listed applicant for Exactech Alteon Monobloc Revision Stem?

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 Monobloc Revision Stem?

The FDA product code for Exactech Alteon Monobloc Revision Stem is LZO.

Other records listing Exactech, Inc. as applicant

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Related Devices (Code: LZO)

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.

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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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