Ebi 5.5 Helical Flange Spinal System

• 2 recalls, same reason

  • Terminated Z-2301-2009 FDA Unclassified (pre-2012) ·initiated 2 Apr 2009 ·on shared 510(k) K061441
  • Terminated Z-2300-2009 FDA Unclassified (pre-2012) ·initiated 2 Apr 2009 ·on shared 510(k) K061441

  Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K061441 ↗

FDA Product Code

MNH

Device Class

Class II

Regulation

21 CFR Part 888.3070

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. →