Bremer Halo System Titanium Skull Pin

• 15 recalls, same reason

  • Terminated Z-0134-2007 FDA Unclassified (pre-2012) ·initiated 10 Oct 2006 ·on shared 510(k) K993099
  • Terminated Z-0130-2007 FDA Unclassified (pre-2012) ·initiated 10 Oct 2006 ·on shared 510(k) K993099
  • Terminated Z-0132-2007 FDA Unclassified (pre-2012) ·initiated 10 Oct 2006 ·on shared 510(k) K993099
  • Terminated Z-0141-2007 FDA Unclassified (pre-2012) ·initiated 10 Oct 2006 ·on shared 510(k) K993099
  • Terminated Z-0140-2007 FDA Unclassified (pre-2012) ·initiated 10 Oct 2006 ·on shared 510(k) K993099
  • Terminated Z-0143-2007 FDA Unclassified (pre-2012) ·initiated 10 Oct 2006 ·on shared 510(k) K993099
  • Terminated Z-0144-2007 FDA Unclassified (pre-2012) ·initiated 10 Oct 2006 ·on shared 510(k) K993099
  • Terminated Z-0133-2007 FDA Unclassified (pre-2012) ·initiated 10 Oct 2006 ·on shared 510(k) K993099
  • Terminated Z-0131-2007 FDA Unclassified (pre-2012) ·initiated 10 Oct 2006 ·on shared 510(k) K993099
  • Terminated Z-0135-2007 FDA Unclassified (pre-2012) ·initiated 10 Oct 2006 ·on shared 510(k) K993099
  • Terminated Z-0136-2007 FDA Unclassified (pre-2012) ·initiated 10 Oct 2006 ·on shared 510(k) K993099
  • Terminated Z-0138-2007 FDA Unclassified (pre-2012) ·initiated 10 Oct 2006 ·on shared 510(k) K993099
  • Terminated Z-0137-2007 FDA Unclassified (pre-2012) ·initiated 10 Oct 2006 ·on shared 510(k) K993099
  • Terminated Z-0142-2007 FDA Unclassified (pre-2012) ·initiated 10 Oct 2006 ·on shared 510(k) K993099
  • Terminated Z-0139-2007 FDA Unclassified (pre-2012) ·initiated 10 Oct 2006 ·on shared 510(k) K993099

  Sterility of device is compromised due to loss of package integrity

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

510(k) Number

K993099 ↗

FDA Product Code

JEC

Device Class

Class II

Regulation

21 CFR Part 888.3040

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Moss Miami Spinal Systems

  Class II

  FDA 510(k) K013296 Active Cleared 9 Oct 2001

• Monarch Spine System

  Class II

  FDA 510(k) K021335 Active Cleared 11 Jul 2002

• Eagle Anterior Cervial Plate System

  Class II

  FDA 510(k) K040197 Active Cleared 2 Apr 2004

• Stackable Cage System

  Class II

  FDA 510(k) K001340 Active Cleared 26 Jul 2000

• Depuy Acromed Vbr System

  Class II

  FDA 510(k) K030833 Active Cleared 10 Apr 2003

• Crossover Cross Connector (Moss Miami Spine System)

  Class II

  FDA 510(k) K021880 Active Cleared 26 Jun 2002

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