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FDA 510(k)

Vanguard XP Knee System

K-Number: K153657 · 2016-05-10

ApplicantBiomet, Inc.
Decision Date2016-05-10
Product CodeMBH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Vanguard XP Knee System is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 2016-05-10 under 510(k) number K153657. 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 XP Knee System?

Vanguard XP Knee System is a medical device that received FDA 510(k) clearance on 2016-05-10. The listed applicant is Biomet, Inc.. The 510(k) number is K153657.

When did Vanguard XP Knee System receive FDA 510(k) clearance?

Vanguard XP Knee System received FDA 510(k) clearance on 2016-05-10, under 510(k) number K153657.

Who is the listed applicant for Vanguard XP Knee System?

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 XP Knee System?

The FDA product code for Vanguard XP Knee System is MBH.

Other records listing Biomet, Inc. as applicant

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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.

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.K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK253239Active-V Total Knee System; World Total Knee SystemSignature Orthopaedics Pty, Ltd.K253161Balanced Knee System TriMax Porous Femoral ComponentsOrtho Development Corp.

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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