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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 a medical device manufactured by Exactech, Inc.. It received FDA 510(k) clearance on 2018-09-04 under approval 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. It is manufactured by Exactech, Inc.. The 510(k) number is K181532.

When was Exactech Alteon Monobloc Revision Stem approved by the FDA?

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

What company makes Exactech Alteon Monobloc Revision Stem?

Exactech Alteon Monobloc Revision Stem is manufactured by Exactech, Inc..

What is the FDA product code for Exactech Alteon Monobloc Revision Stem?

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

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Related Devices (Code: LZO)

K160895Initia Total Hip System & BIOCERAM AZUL(R) HEADKyocera Medical Corporation K161830Zimmer M/L Taper Hip ProsthesisZimmer, Inc. K161192Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® SystemZimmer GmbH K152893Corin Optimized Positioning System (OPS)Corin USA K160289MasterLoc StemMedacta International K152903REVIVAL(TM) Modular Revision Hip StemCorin USA

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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