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FDA 510(k)

SMS Femoral Stem

K-Number: K181693 · 2018-11-28

ApplicantMedacta International S.A.
Decision Date2018-11-28
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SMS Femoral Stem is a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2018-11-28 under approval number K181693. 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 SMS Femoral Stem?

SMS Femoral Stem is a medical device that received FDA 510(k) clearance on 2018-11-28. It is manufactured by Medacta International S.A.. The 510(k) number is K181693.

When was SMS Femoral Stem approved by the FDA?

SMS Femoral Stem received FDA 510(k) clearance on 2018-11-28, under approval number K181693.

What company makes SMS Femoral Stem?

SMS Femoral Stem is manufactured by Medacta International S.A..

What is the FDA product code for SMS Femoral Stem?

The FDA product code for SMS Femoral Stem is LZO.

Other Devices by Medacta International S.A.

K163311GMK Revision Femoral Distal Augmentation K162061M.U.S.T. Pedicle Screw System K153273MySpine Pedicle Screw Placement Guides - LP K171058Medacta Shoulder System: Threaded Glenoid Baseplate K173267MasterLoc Stem: Lateralized Plus K170690M-Vizion Femoral Revision System

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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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