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FDA 510(k)

Avenir Muller Stem, Avenir Cemented Hip Stem

K-Number: K193030 · 2019-12-06

ApplicantZimmer GmbH
Decision Date2019-12-06
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Avenir Muller Stem, Avenir Cemented Hip Stem is a medical device manufactured by Zimmer GmbH. It received FDA 510(k) clearance on 2019-12-06 under approval number K193030. 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 Avenir Muller Stem, Avenir Cemented Hip Stem?

Avenir Muller Stem, Avenir Cemented Hip Stem is a medical device that received FDA 510(k) clearance on 2019-12-06. It is manufactured by Zimmer GmbH. The 510(k) number is K193030.

When was Avenir Muller Stem, Avenir Cemented Hip Stem approved by the FDA?

Avenir Muller Stem, Avenir Cemented Hip Stem received FDA 510(k) clearance on 2019-12-06, under approval number K193030.

What company makes Avenir Muller Stem, Avenir Cemented Hip Stem?

Avenir Muller Stem, Avenir Cemented Hip Stem is manufactured by Zimmer GmbH.

What is the FDA product code for Avenir Muller Stem, Avenir Cemented Hip Stem?

The FDA product code for Avenir Muller Stem, Avenir Cemented Hip 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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