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FDA 510(k)

DURACON X3 CS TIBIAL INSERT

K-Number: K070883 · 2007-05-11

ApplicantHowmedica Osteonics Corp.
Decision Date2007-05-11
Product CodeMBH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DURACON X3 CS TIBIAL INSERT is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Osteonics Corp.. It received FDA 510(k) clearance on 2007-05-11 under 510(k) number K070883. 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 DURACON X3 CS TIBIAL INSERT?

DURACON X3 CS TIBIAL INSERT is a medical device that received FDA 510(k) clearance on 2007-05-11. The listed applicant is Howmedica Osteonics Corp.. The 510(k) number is K070883.

When did DURACON X3 CS TIBIAL INSERT receive FDA 510(k) clearance?

DURACON X3 CS TIBIAL INSERT received FDA 510(k) clearance on 2007-05-11, under 510(k) number K070883.

Who is the listed applicant for DURACON X3 CS TIBIAL INSERT?

The FDA 510(k) record lists Howmedica Osteonics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DURACON X3 CS TIBIAL INSERT?

The FDA product code for DURACON X3 CS TIBIAL INSERT 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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