Lanx Spinal Fixation System

• • Terminated Z-1146-2015 FDA Class II ·initiated 30 Nov 2012

  Biomet Spine LLC is recalling the Set Screw 5.5 mm Rod due to the set screw being out of specification

510(k) Number

K122145 ↗

FDA Product Code

NKB

Device Class

Class II

Regulation

21 CFR Part 888.3070

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Lanx Spinal Fixation System

  Class II

  FDA 510(k) K043484 Active Cleared 16 May 2005

• Modification to Lanx Posterior Cervicothoracic Spinal Fixation System

  Class II

  FDA 510(k) K100888 Active Cleared 15 Nov 2010

• Lanx Cervical Intervertebral Body Fusion System

  Class II

  FDA 510(k) K103660 Active Cleared 28 Feb 2011

• Lanx Anterior Cervial Plate System

  Class II

  FDA 510(k) K040401 Active Cleared 12 Apr 2004

• Lanx Anterior Plating System

  Class II

  FDA 510(k) K092765 Active Cleared 7 Apr 2010

• Lanx Posterior Cervicothoracic Spinal Fixation System (Pcfs)

  Class II

  FDA 510(k) K113434 Active Cleared 19 Dec 2011

See all devices from Lanx, Inc. →