FDA 510(k)

Revival Modular Hip Stem

K-Number: K191374 · 2019-07-22

Decision Date2019-07-22

Product CodeLZO

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Revival Modular Hip Stem is a medical device manufactured by Corin U.S.A. Limited. It received FDA 510(k) clearance on 2019-07-22 under approval number K191374. 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 Revival Modular Hip Stem?

Revival Modular Hip Stem is a medical device that received FDA 510(k) clearance on 2019-07-22. It is manufactured by Corin U.S.A. Limited. The 510(k) number is K191374.

When was Revival Modular Hip Stem approved by the FDA?

Revival Modular Hip Stem received FDA 510(k) clearance on 2019-07-22, under approval number K191374.

What company makes Revival Modular Hip Stem?

Revival Modular Hip Stem is manufactured by Corin U.S.A. Limited.

What is the FDA product code for Revival Modular Hip Stem?

The FDA product code for Revival Modular Hip Stem is LZO.

Other Devices by Corin U.S.A. Limited

K153772Corin TriFit TS Hip K153725Corin TaperFit Hip Stem K153381Corin Metafix Hip Stem K170359Trinity Dual Mobility System K170808Unity Total Knee System K162942Corin MetaFix Hip Stem

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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.