Modification to Blackstone Modular Pedicle Screw System

• • Terminated Z-1655-2009 FDA Unclassified (pre-2012) ·initiated 21 May 2009

  Product marketed without an approved 510(k)

• • Terminated Z-0716-06 FDA Unclassified (pre-2012) ·initiated 23 Dec 2005 ·on shared 510(k) K042514

  Pedicle Screw may disengage in post op period requiring intervention

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

510(k) Number

K042514 ↗

FDA Product Code

MNI

Device Class

Class II

Regulation

21 CFR Part 888.3070

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Blakstone Laminoplasty Fixation System

  Class II

  FDA 510(k) K043338 Active Cleared 18 Feb 2005

• Blackstone Spinal Fixation System Posterior Hooks

  Class II

  FDA 510(k) K013885 Active Cleared 1 Feb 2002

• Blackstone Peek Vertebral Body Replacement System

  Class II

  FDA 510(k) K033702 Active Cleared 31 Mar 2004

• Blackstone Surgical Titanium Mesh System Angled End Rings

  Class II

  FDA 510(k) K032700 Active Cleared 9 Oct 2003

• Blackstone Ascent Poct System 5.5mm/3.0mm Single Axial Connector

  Class II

  FDA 510(k) K042100 Active Cleared 20 Sep 2004

• Blackstone Medical Inc. Anterior Cervical Plate System

  Class II

  FDA 510(k) K974885 Active Cleared 17 Jun 1998

See all devices from Blackstone Medical, Inc. →