Synthes T-Pal Spacer

• • Terminated Z-0161-2012 FDA Unclassified (pre-2012) ·initiated 23 Sep 2011

  LABELING CORRECTION for Medical Device - previous labeling and promotional materials associated with the T-PAL Spacer system reference the use of T-PAL spacer with allograft material. T-PAL Spacer is currently indicated for use with autograft material. All accounts with record of receiving T-PAL Implant will receive notification of the labeling correction and a copy of the updated brochure. All

510(k) Number

K100089 ↗

FDA Product Code

MAX

Device Class

Class II

Regulation

21 CFR Part 888.3080

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Uss Iliosacral, Uss Polyaxial

  Class II

  FDA 510(k) K082572 Active Cleared 24 Nov 2008

• Oracle Spacer, Opal Spacer

  Class II

  FDA 510(k) K072791 Active Cleared 26 Dec 2007

• Synthes Mirs

  Class II

  FDA 510(k) K113044 Active Cleared 21 Dec 2011

• Synthes Spine Posterior Universal System

  Class II

  FDA 510(k) K984612 Active Cleared 19 Jan 1999

• Synthes Cervifix System

  Class II

  FDA 510(k) K001864 Active Cleared 20 Jul 2000

• Synthes Spine Universal Spinal Hook, Rod, Pedicle/Sacral Screw Fixation System

  Class II

  FDA 510(k) K980928 Active Cleared 11 May 1998

See all devices from Synthes Spine →