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FDA 510(k)

REJUVENATE MODULAR STEM

K-Number: K092561 · 2009-10-20

ApplicantHowmedica Osteonics Corp.
Decision Date2009-10-20
Product CodeMEH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

REJUVENATE MODULAR 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 2009-10-20 under 510(k) number K092561. 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 REJUVENATE MODULAR STEM?

REJUVENATE MODULAR STEM is a medical device that received FDA 510(k) clearance on 2009-10-20. The listed applicant is Howmedica Osteonics Corp.. The 510(k) number is K092561.

When did REJUVENATE MODULAR STEM receive FDA 510(k) clearance?

REJUVENATE MODULAR STEM received FDA 510(k) clearance on 2009-10-20, under 510(k) number K092561.

Who is the listed applicant for REJUVENATE MODULAR 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 REJUVENATE MODULAR STEM?

The FDA product code for REJUVENATE MODULAR STEM is MEH.

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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

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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