FDA 510(k)

Corin Metafix Hip Stem

K-Number: K153381 · 2016-01-21

Decision Date2016-01-21

Product CodeLZO

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Corin Metafix Hip Stem is a medical device manufactured by Corin U.S.A. Limited. It received FDA 510(k) clearance on 2016-01-21 under approval number K153381. 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 Corin Metafix Hip Stem?

Corin Metafix Hip Stem is a medical device that received FDA 510(k) clearance on 2016-01-21. It is manufactured by Corin U.S.A. Limited. The 510(k) number is K153381.

When was Corin Metafix Hip Stem approved by the FDA?

Corin Metafix Hip Stem received FDA 510(k) clearance on 2016-01-21, under approval number K153381.

What company makes Corin Metafix Hip Stem?

Corin Metafix Hip Stem is manufactured by Corin U.S.A. Limited.

What is the FDA product code for Corin Metafix Hip Stem?

The FDA product code for Corin Metafix Hip Stem is LZO.

Other Devices by Corin U.S.A. Limited

K153772Corin TriFit TS Hip K153725Corin TaperFit Hip Stem K170359Trinity Dual Mobility System K170808Unity Total Knee System K162942Corin MetaFix Hip Stem K172551Trinity PLUS Acetabular Shell

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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.