Stabilization Screw

• • Terminated Z-1253-2010 FDA Unclassified (pre-2012) ·initiated 8 Feb 2010

  The screws were etched incorrectly as 34mm instead of the correct 32mm.

• • Terminated Z-1254-2010 FDA Unclassified (pre-2012) ·initiated 8 Feb 2010

  The screws were etched incorrectly as 32mm instead of the correct 34mm length.

• • Terminated Z-1445-2008 FDA Unclassified (pre-2012) ·initiated 27 Feb 2008

  Certain QWIX Fixation Screws (Reference numbers 111426S and 111428S) have been etched and labelled with an incorrect length.

• • Terminated Z-1446-2008 FDA Unclassified (pre-2012) ·initiated 27 Feb 2008

  Certain QWIX Fixation Screws (Part numbers 111426s and 111428s) have been etched and labelled with an incorrect length.

510(k) Number

K050346 ↗

FDA Product Code

HWC

Device Class

Class II

Regulation

21 CFR Part 888.3040

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Solustaple

  Class II

  FDA 510(k) K991566 Active Cleared 3 Aug 1999

• Modification to Ttc Plates

  Class II

  FDA 510(k) K070160 Active Cleared 8 Feb 2007

• Bold Screw

  Class II

  FDA 510(k) K990622 Active Cleared 29 Apr 1999

• The Uni-Clip Staple

  Class II

  FDA 510(k) K011716 Active Cleared 30 Aug 2001

• Kalix II Implant

  Class II

  FDA 510(k) K061765 Active Cleared 18 Jul 2006

• Spin Snap-Off Screw

  Class II

  FDA 510(k) K991477 Active Cleared 14 Jul 1999

See all devices from New Deal, S.A. →