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FDA 510(k)

OMEGA 2 SYSTEM

K-Number: K041001 · 2004-07-01

ApplicantHowmedica Osteonics Corp.
Decision Date2004-07-01
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OMEGA 2 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 2004-07-01 under 510(k) number K041001. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMEGA 2 SYSTEM?

OMEGA 2 SYSTEM is a medical device that received FDA 510(k) clearance on 2004-07-01. The listed applicant is Howmedica Osteonics Corp.. The 510(k) number is K041001.

When did OMEGA 2 SYSTEM receive FDA 510(k) clearance?

OMEGA 2 SYSTEM received FDA 510(k) clearance on 2004-07-01, under 510(k) number K041001.

Who is the listed applicant for OMEGA 2 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 OMEGA 2 SYSTEM?

The FDA product code for OMEGA 2 SYSTEM is KTT.

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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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