Cannulated Screw System

• • Terminated Z-0872-06 FDA Unclassified (pre-2012) ·initiated 3 Mar 2006 ·on shared 510(k) K003496

  There may be an obstruction in the cannula that will prevent the guide wire from passing through it. The obstruction in the cannula can force the guidewire to advance further into the patient than intended.

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

510(k) Number

K003496 ↗

FDA product code

HTN

Device class

Class II

Regulation

21 CFR Part 888.3030

Advisory committee

Orthopedic

FDA decision

SESE Substantially Equivalent

• Pacp

  Class II

  FDA 510(k) K083663 Active Cleared 25 Feb 2009

• Modification to: Pioneer Surgical Technology Quantum Spinal System

  Class II

  FDA 510(k) K070551 Active Cleared 29 Mar 2007

• Tritium Sternal Cable Plate System

  Class II

  FDA 510(k) K193468 Active Cleared 12 Mar 2020

• Pioneer Vertebral Spacer (Vertebral Spacer)

  Class II

  FDA 510(k) K061151 Active Cleared 24 Jul 2006

• Quantum/ Streamline Spinal System Model 02-Series and 10-Series

  Class II

  FDA 510(k) K093692 Active Cleared 11 Aug 2010

• Quantum/Streamline Tl Mis Spinal System

  Class II

  FDA 510(k) K093771 Active Cleared 10 Aug 2010

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