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FDA 510(k)

LEGION CR Porous Plus HA Femoral Components

K-Number: K211246 · 2021-05-24

ApplicantSmith & Nephew, Inc.
Decision Date2021-05-24
Product CodeMBH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LEGION CR Porous Plus HA Femoral Components is a medical device manufactured by Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2021-05-24 under approval number K211246. The device is classified under product code MBH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LEGION CR Porous Plus HA Femoral Components?

LEGION CR Porous Plus HA Femoral Components is a medical device that received FDA 510(k) clearance on 2021-05-24. It is manufactured by Smith & Nephew, Inc.. The 510(k) number is K211246.

When was LEGION CR Porous Plus HA Femoral Components approved by the FDA?

LEGION CR Porous Plus HA Femoral Components received FDA 510(k) clearance on 2021-05-24, under approval number K211246.

What company makes LEGION CR Porous Plus HA Femoral Components?

LEGION CR Porous Plus HA Femoral Components is manufactured by Smith & Nephew, Inc..

What is the FDA product code for LEGION CR Porous Plus HA Femoral Components?

The FDA product code for LEGION CR Porous Plus HA Femoral Components is MBH.

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Related Devices (Code: MBH)

K162256Klassic Femur, Porous, Klassic Tibial Baseplate, PorousTotal Joint Orthopedics, Inc. K153657Vanguard XP Knee SystemBiomet, Inc. K153776Optetrak One Logic Femoral ComponentsExactech, Inc. K153586Arthrex iBalance TKA SystemArthrex, Inc. K172634Triathlon® X3® UHMWPE Tibial Inserts and Patellar ComponentsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics K171365Arthrex Knee SystemsArthrex, Inc.

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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