Blackstone Posterior Cervical System

• • Terminated Z-1144-2010 FDA Unclassified (pre-2012) ·initiated 2 Feb 2010 ·on shared 510(k) K030197

  The Ascent Posterior Occipital Cervical Thoracic System Single Looped Cable with two crimps may be made of stainless steel instead of Titanium.

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

510(k) Number

K030197 ↗

FDA Product Code

KWP

Device Class

Class II

Regulation

21 CFR Part 888.3050

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

• Modification to Blackstone Modular Pedicle Screw System

  Class II

  FDA 510(k) K042514 Active Cleared 7 Oct 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

See all devices from Blackstone Medical, Inc. →