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FDA 510(k)

TITAN TIBIAL NAIL

K-Number: K003018 · 2000-12-15

ApplicantHowmedica Osteonics Corp.
Decision Date2000-12-15
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TITAN TIBIAL 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 2000-12-15 under 510(k) number K003018. 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 TITAN TIBIAL NAIL?

TITAN TIBIAL NAIL is a medical device that received FDA 510(k) clearance on 2000-12-15. The listed applicant is Howmedica Osteonics Corp.. The 510(k) number is K003018.

When did TITAN TIBIAL NAIL receive FDA 510(k) clearance?

TITAN TIBIAL NAIL received FDA 510(k) clearance on 2000-12-15, under 510(k) number K003018.

Who is the listed applicant for TITAN TIBIAL 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 TITAN TIBIAL NAIL?

The FDA product code for TITAN TIBIAL NAIL is HSB.

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Related Devices (Code: 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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