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FDA 510(k)

MODIFICATION TO MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEMS

K-Number: K040128 · 2004-03-26

ApplicantHowmedica Osteonics Corp.
Decision Date2004-03-26
Product CodeHSD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEMS 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 2004-03-26 under 510(k) number K040128. The device is classified under product code HSD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEMS?

MODIFICATION TO MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEMS is a medical device that received FDA 510(k) clearance on 2004-03-26. The listed applicant is Howmedica Osteonics Corp.. The 510(k) number is K040128.

When did MODIFICATION TO MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEMS receive FDA 510(k) clearance?

MODIFICATION TO MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEMS received FDA 510(k) clearance on 2004-03-26, under 510(k) number K040128.

Who is the listed applicant for MODIFICATION TO MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEMS?

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 MODIFICATION TO MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEMS?

The FDA product code for MODIFICATION TO MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEMS is HSD.

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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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