FDA 510(k)

LEGION POROUS + HA TIBIAL BASEPLATES

K-Number: K100897 · 2010-05-13

Decision Date2010-05-13

Product CodeMBH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

LEGION POROUS + HA TIBIAL BASEPLATES is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2010-05-13 under 510(k) number K100897. 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 POROUS + HA TIBIAL BASEPLATES?

LEGION POROUS + HA TIBIAL BASEPLATES is a medical device that received FDA 510(k) clearance on 2010-05-13. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K100897.

When did LEGION POROUS + HA TIBIAL BASEPLATES receive FDA 510(k) clearance?

LEGION POROUS + HA TIBIAL BASEPLATES received FDA 510(k) clearance on 2010-05-13, under 510(k) number K100897.

Who is the listed applicant for LEGION POROUS + HA TIBIAL BASEPLATES?

The FDA 510(k) record lists Smith & Nephew, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LEGION POROUS + HA TIBIAL BASEPLATES?

The FDA product code for LEGION POROUS + HA TIBIAL BASEPLATES is MBH.

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Other records listing Smith & Nephew, Inc. as applicant

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Related Devices (Code: MBH)

K261275Unity Total Knee System, Unity Knee Cementless CR FemurCorin, Ltd.K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc.K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc.K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc.K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.