Ebi Optilock Upper Extremity Plating System

• • Terminated Z-1439-2012 FDA Not yet classified ·initiated 15 Mar 2012

  Biomet initiated this action after a complaint was received that item 36728, Non-Locking Screw 3.5mm x 28mm was in a package labeled as 37728, Locking Screw 3.5mm x 28mm.

510(k) Number

K062494 ↗

FDA Product Code

HRS

Device Class

Class II

Regulation

21 CFR Part 888.3030

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

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