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FDA 510(k)

TMZF PRESS FIT HA STEM AND TMZF PRESS FIT PLUS HA STEM

K-Number: K994366 · 2000-03-16

ApplicantHowmedica Osteonics Corp.
Decision Date2000-03-16
Product CodeMEH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TMZF PRESS FIT HA STEM AND TMZF PRESS FIT PLUS HA STEM 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 2000-03-16 under 510(k) number K994366. The device is classified under product code MEH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TMZF PRESS FIT HA STEM AND TMZF PRESS FIT PLUS HA STEM?

TMZF PRESS FIT HA STEM AND TMZF PRESS FIT PLUS HA STEM is a medical device that received FDA 510(k) clearance on 2000-03-16. The listed applicant is Howmedica Osteonics Corp.. The 510(k) number is K994366.

When did TMZF PRESS FIT HA STEM AND TMZF PRESS FIT PLUS HA STEM receive FDA 510(k) clearance?

TMZF PRESS FIT HA STEM AND TMZF PRESS FIT PLUS HA STEM received FDA 510(k) clearance on 2000-03-16, under 510(k) number K994366.

Who is the listed applicant for TMZF PRESS FIT HA STEM AND TMZF PRESS FIT PLUS HA STEM?

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 TMZF PRESS FIT HA STEM AND TMZF PRESS FIT PLUS HA STEM?

The FDA product code for TMZF PRESS FIT HA STEM AND TMZF PRESS FIT PLUS HA STEM is MEH.

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Other records listing Howmedica Osteonics Corp. as applicant

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Related Devices (Code: MEH)

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.

K261576Icona Hip StemCorin, Ltd.K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KGK251166Mfinity Femoral SystemMedacta International S.A.K251052Trivicta® Hip StemOrtho Development Corp.K242315Resolve Modular Revision Hip StemUnited Orthopedic CorporationK243839Alteon® HA Femoral StemsExactech, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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