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FDA 510(k)

UNITRAX MODULAR UNIPOLAR SYSTEM

K-Number: K014226 · 2002-01-25

ApplicantHowmedica Osteonics Corp.
Decision Date2002-01-25
Product CodeKWL
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

UNITRAX MODULAR UNIPOLAR SYSTEM 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 2002-01-25 under 510(k) number K014226. The device is classified under product code KWL. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNITRAX MODULAR UNIPOLAR SYSTEM?

UNITRAX MODULAR UNIPOLAR SYSTEM is a medical device that received FDA 510(k) clearance on 2002-01-25. The listed applicant is Howmedica Osteonics Corp.. The 510(k) number is K014226.

When did UNITRAX MODULAR UNIPOLAR SYSTEM receive FDA 510(k) clearance?

UNITRAX MODULAR UNIPOLAR SYSTEM received FDA 510(k) clearance on 2002-01-25, under 510(k) number K014226.

Who is the listed applicant for UNITRAX MODULAR UNIPOLAR SYSTEM?

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 UNITRAX MODULAR UNIPOLAR SYSTEM?

The FDA product code for UNITRAX MODULAR UNIPOLAR SYSTEM is KWL.

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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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