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FDA 510(k)

NEXGEN POROUS, HA/TCP, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE COMPONENTS

K-Number: K041100 · 2004-10-29

ApplicantZimmer, Inc.
Decision Date2004-10-29
Product CodeMBH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NEXGEN POROUS, HA/TCP, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE COMPONENTS is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer, Inc.. It received FDA 510(k) clearance on 2004-10-29 under 510(k) number K041100. 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 NEXGEN POROUS, HA/TCP, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE COMPONENTS?

NEXGEN POROUS, HA/TCP, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE COMPONENTS is a medical device that received FDA 510(k) clearance on 2004-10-29. The listed applicant is Zimmer, Inc.. The 510(k) number is K041100.

When did NEXGEN POROUS, HA/TCP, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE COMPONENTS receive FDA 510(k) clearance?

NEXGEN POROUS, HA/TCP, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE COMPONENTS received FDA 510(k) clearance on 2004-10-29, under 510(k) number K041100.

Who is the listed applicant for NEXGEN POROUS, HA/TCP, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE COMPONENTS?

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

What is the FDA product code for NEXGEN POROUS, HA/TCP, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE COMPONENTS?

The FDA product code for NEXGEN POROUS, HA/TCP, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE COMPONENTS is MBH.

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Related Devices (Code: MBH)

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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

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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