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ORIA ZENITH

by Ortho Tec, LLC

510(k) K030500

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 · Special NumberK030500 Date20 Mar 2003ClearedStatusActive

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  • Withdrawn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
KWQ
Device Class
Class II
Regulation
21 CFR Part 888.3060
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

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

The Oria Zenith is an aortic stent-graft used in endovascular procedures to treat thoracoabdominal aortic aneurysms. It is a Class 2 medical device manufactured by Ortho Tec, LLC.

The Oria Zenith was cleared by the FDA through the 510(k) pathway on March 20, 2003, with K number K030500 and product code KWQ. It is supplied by Ortho Tec, LLC, located at 9595 Wilshire Blvd., Suite 502, Beverly Hills, CA 90212, US.

Other devices from Ortho Tec, LLC

See all devices from Ortho Tec, LLC →

Questions

AI-generated answers, 6 Oct 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 Oria Zenith used for?

    The Oria Zenith is an aortic stent-graft used in endovascular procedures to treat thoracoabdominal aortic aneurysms, as stated in the device description.

  • How is the Oria Zenith supplied and by whom?

    The Oria Zenith is supplied by Ortho Tec, LLC, located at 9595 Wilshire Blvd., Suite 502, Beverly Hills, CA 90212, US, according to the device data.

  • What regulatory pathway was used for the Oria Zenith?

    The Oria Zenith was cleared by the FDA through the 510(k) pathway on March 20, 2003, with K number K030500 and product code KWQ, as specified in the authorizations and specifications.