Galileo Cas/Nav Tkr System

• • Terminated Z-0149-2007 FDA Unclassified (pre-2012) ·initiated 20 Jun 2006

  Manufacturer recall of the device due to the possibility of pressure plate fractures/breakage.

510(k) Number

K020298 ↗

FDA Product Code

HAW

Device Class

Class II

Regulation

21 CFR Part 882.4560

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• Rt-Plus Modular Cemented Knee Components

  Class II

  FDA 510(k) K003504 Active Cleared 11 May 2001

• Plus Bipolar Prosthesis Cocrmo

  Class II

  FDA 510(k) K982447 Active Cleared 25 Nov 1998

• Tc-Plus Porous Tibial Components

  Class II

  FDA 510(k) K011288 Active Cleared 24 May 2001

• Modification to Slim Gliding Nail System

  Class II

  FDA 510(k) K033763 Active Cleared 18 Dec 2003

• Uc-Plus Solution Unicondylar Knee

  Class II

  FDA 510(k) K032052 Active Cleared 25 Jul 2003

• Pe-Plus Acetabular Cup

  Class II

  FDA 510(k) K992153 Active Cleared 23 Sep 1999

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