Ebi Aray Spinal System

• • Terminated Z-0131-2011 FDA Unclassified (pre-2012) ·initiated 16 Sep 2010

  One of the two connector ends of the medium cross connector may not be fully secured to the rod after tightening. This may not be readily apparent to the operating surgeon, resulting in inadequate torsional stability.

510(k) Number

K062685 ↗

FDA Product Code

NKB

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

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  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

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• 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

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