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FDA 510(k)

DURACON TOTAL KNEE SYSTEM WITH PERI-APATITE COATING

K-Number: K032418 · 2003-09-11

ApplicantHowmedica Osteonics Corp.
Decision Date2003-09-11
Product CodeMBH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DURACON TOTAL KNEE SYSTEM WITH PERI-APATITE COATING 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 2003-09-11 under 510(k) number K032418. 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 TOTAL KNEE SYSTEM WITH PERI-APATITE COATING?

DURACON TOTAL KNEE SYSTEM WITH PERI-APATITE COATING is a medical device that received FDA 510(k) clearance on 2003-09-11. The listed applicant is Howmedica Osteonics Corp.. The 510(k) number is K032418.

When did DURACON TOTAL KNEE SYSTEM WITH PERI-APATITE COATING receive FDA 510(k) clearance?

DURACON TOTAL KNEE SYSTEM WITH PERI-APATITE COATING received FDA 510(k) clearance on 2003-09-11, under 510(k) number K032418.

Who is the listed applicant for DURACON TOTAL KNEE SYSTEM WITH PERI-APATITE COATING?

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 TOTAL KNEE SYSTEM WITH PERI-APATITE COATING?

The FDA product code for DURACON TOTAL KNEE SYSTEM WITH PERI-APATITE COATING 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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