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FDA 510(k)

Exactech Alteon Modular Dual Mobility (MDM) System

K-Number: K190890 · 2019-10-22

ApplicantExactech, Inc.
Decision Date2019-10-22
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Exactech Alteon Modular Dual Mobility (MDM) System is the device name listed in this FDA 510(k) record. The listed applicant is Exactech, Inc.. It received FDA 510(k) clearance on 2019-10-22 under 510(k) number K190890. 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 Modular Dual Mobility (MDM) System?

Exactech Alteon Modular Dual Mobility (MDM) System is a medical device that received FDA 510(k) clearance on 2019-10-22. The listed applicant is Exactech, Inc.. The 510(k) number is K190890.

When did Exactech Alteon Modular Dual Mobility (MDM) System receive FDA 510(k) clearance?

Exactech Alteon Modular Dual Mobility (MDM) System received FDA 510(k) clearance on 2019-10-22, under 510(k) number K190890.

Who is the listed applicant for Exactech Alteon Modular Dual Mobility (MDM) System?

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 Modular Dual Mobility (MDM) System?

The FDA product code for Exactech Alteon Modular Dual Mobility (MDM) System 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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