FDA 510(k)

OSTEO IC FEMORAL AND TIBIAL NAILS IN TITANIUM ALLOY

K-Number: K992063 · 1999-09-03

Decision Date1999-09-03

Product CodeHSB

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

OSTEO IC FEMORAL AND TIBIAL NAILS IN TITANIUM ALLOY 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 1999-09-03 under 510(k) number K992063. 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 OSTEO IC FEMORAL AND TIBIAL NAILS IN TITANIUM ALLOY?

OSTEO IC FEMORAL AND TIBIAL NAILS IN TITANIUM ALLOY is a medical device that received FDA 510(k) clearance on 1999-09-03. The listed applicant is Howmedica Osteonics Corp.. The 510(k) number is K992063.

When did OSTEO IC FEMORAL AND TIBIAL NAILS IN TITANIUM ALLOY receive FDA 510(k) clearance?

OSTEO IC FEMORAL AND TIBIAL NAILS IN TITANIUM ALLOY received FDA 510(k) clearance on 1999-09-03, under 510(k) number K992063.

Who is the listed applicant for OSTEO IC FEMORAL AND TIBIAL NAILS IN TITANIUM ALLOY?

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 OSTEO IC FEMORAL AND TIBIAL NAILS IN TITANIUM ALLOY?

The FDA product code for OSTEO IC FEMORAL AND TIBIAL NAILS IN TITANIUM ALLOY is HSB.

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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.