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FDA 510(k)

MasterLoc Stem: Lateralized Plus

K-Number: K173267 · 2017-12-07

ApplicantMedacta International S.A.
Decision Date2017-12-07
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MasterLoc Stem: Lateralized Plus is a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2017-12-07 under approval number K173267. 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 MasterLoc Stem: Lateralized Plus?

MasterLoc Stem: Lateralized Plus is a medical device that received FDA 510(k) clearance on 2017-12-07. It is manufactured by Medacta International S.A.. The 510(k) number is K173267.

When was MasterLoc Stem: Lateralized Plus approved by the FDA?

MasterLoc Stem: Lateralized Plus received FDA 510(k) clearance on 2017-12-07, under approval number K173267.

What company makes MasterLoc Stem: Lateralized Plus?

MasterLoc Stem: Lateralized Plus is manufactured by Medacta International S.A..

What is the FDA product code for MasterLoc Stem: Lateralized Plus?

The FDA product code for MasterLoc Stem: Lateralized Plus 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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