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FDA 510(k)

T2 PROXIMAL HUMERAL NAIL

K-Number: K042396 · 2004-10-08

ApplicantHowmedica Osteonics Corp.
Decision Date2004-10-08
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

T2 PROXIMAL HUMERAL NAIL 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 2004-10-08 under 510(k) number K042396. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the T2 PROXIMAL HUMERAL NAIL?

T2 PROXIMAL HUMERAL NAIL is a medical device that received FDA 510(k) clearance on 2004-10-08. The listed applicant is Howmedica Osteonics Corp.. The 510(k) number is K042396.

When did T2 PROXIMAL HUMERAL NAIL receive FDA 510(k) clearance?

T2 PROXIMAL HUMERAL NAIL received FDA 510(k) clearance on 2004-10-08, under 510(k) number K042396.

Who is the listed applicant for T2 PROXIMAL HUMERAL NAIL?

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 T2 PROXIMAL HUMERAL NAIL?

The FDA product code for T2 PROXIMAL HUMERAL NAIL is HSB.

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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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