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FDA 510(k)

VANGUARD ANTERIOR STABILIZED TIBIAL BEARINGS

K-Number: K050222 · 2005-08-16

ApplicantBiomet, Inc.
Decision Date2005-08-16
Product CodeMBH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

VANGUARD ANTERIOR STABILIZED TIBIAL BEARINGS is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 2005-08-16 under 510(k) number K050222. 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 VANGUARD ANTERIOR STABILIZED TIBIAL BEARINGS?

VANGUARD ANTERIOR STABILIZED TIBIAL BEARINGS is a medical device that received FDA 510(k) clearance on 2005-08-16. The listed applicant is Biomet, Inc.. The 510(k) number is K050222.

When did VANGUARD ANTERIOR STABILIZED TIBIAL BEARINGS receive FDA 510(k) clearance?

VANGUARD ANTERIOR STABILIZED TIBIAL BEARINGS received FDA 510(k) clearance on 2005-08-16, under 510(k) number K050222.

Who is the listed applicant for VANGUARD ANTERIOR STABILIZED TIBIAL BEARINGS?

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

What is the FDA product code for VANGUARD ANTERIOR STABILIZED TIBIAL BEARINGS?

The FDA product code for VANGUARD ANTERIOR STABILIZED TIBIAL BEARINGS 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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