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Omega 2 System

by Howmedica Osteonics Corp.

510(k) K041001

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK041001 Date1 Jul 2004ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
KTT
Device class
Class II
Regulation
21 CFR Part 888.3030
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Omega 2 System is an orthopedic device. It is classified under the product code KTT.

The Omega 2 System is supplied by Howmedica Osteonics Corp. It has been cleared under the FDA 510K authorization, with the k number K041001. The device is associated with a traditional clearance type and is described as substantially equivalent.

Other devices from Howmedica Osteonics Corp.

See all devices from Howmedica Osteonics Corp. →

Questions

AI-generated answers, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Omega 2 System used for?

    The Omega 2 System is used for orthopedic purposes, classified under product code KTT.

  • How is the Omega 2 System supplied?

    The Omega 2 System is supplied by Howmedica Osteonics Corp.

  • What is the regulatory status of the Omega 2 System?

    The Omega 2 System has been cleared under the FDA 510K authorization with k number K041001, described as substantially equivalent.