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FDA 510(k)

NEXGEN TRABECULAR METAL TIBIAL TRAY

K-Number: K072160 · 2007-09-05

ApplicantZimmer, Inc.
Decision Date2007-09-05
Product CodeMBH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NEXGEN TRABECULAR METAL TIBIAL TRAY is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer, Inc.. It received FDA 510(k) clearance on 2007-09-05 under 510(k) number K072160. 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 TRABECULAR METAL TIBIAL TRAY?

NEXGEN TRABECULAR METAL TIBIAL TRAY is a medical device that received FDA 510(k) clearance on 2007-09-05. The listed applicant is Zimmer, Inc.. The 510(k) number is K072160.

When did NEXGEN TRABECULAR METAL TIBIAL TRAY receive FDA 510(k) clearance?

NEXGEN TRABECULAR METAL TIBIAL TRAY received FDA 510(k) clearance on 2007-09-05, under 510(k) number K072160.

Who is the listed applicant for NEXGEN TRABECULAR METAL TIBIAL TRAY?

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 TRABECULAR METAL TIBIAL TRAY?

The FDA product code for NEXGEN TRABECULAR METAL TIBIAL TRAY is MBH.

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Related Devices (Code: MBH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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