Modification to Omega 21 System

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K001357 ↗

FDA Product Code

KWQ

Device Class

Class II

Regulation

21 CFR Part 888.3060

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Modification to Ebi Xfix Dfs System

  Class II

  FDA 510(k) K023324 Active Cleared 18 Oct 2002

• Ebi Vuelock Anterior Cervical Plate System

  Class II

  FDA 510(k) K023133 Active Cleared 18 Oct 2002

• Ebi Spinelink - II Spinal Fixation System

  Class II

  FDA 510(k) K031355 Active Cleared 22 Jul 2003

• Modification to Ebi Targetcath Fluoro-Guided Steerable Catheter System

  Class II

  FDA 510(k) K032390 Active Cleared 29 Aug 2003

• Array Spinal System Line Extension

  Class II

  FDA 510(k) K061978 Active Cleared 11 Aug 2006

• Ebi P148 Spinal Fixation System

  Class II

  FDA 510(k) K031423 Active Cleared 27 Jun 2003

See all devices from Ebi, L.P. →