Synthes Anterior Cslp System

• • Terminated Z-1524-2016 FDA Class II ·initiated 6 Jan 2016

  DePuy Synthes is initiating a Voluntary Medical Device Recall of lot # 9666776 and 9671879 of Cancellous and Cortex 4.0 mm Screws, which are a part of the Cervical Spine Locking Plate (CSLP) System due to discovery of a single lot of 450.136 screws (4mm Cancellous Self Tapping Screw, Length 16mm, lot 9666776) being swapped with a single lot of 450.016 (4mm Cortex Standard Screw, length 16 mm, lot 9671879).

510(k) Number

K000536 ↗

FDA Product Code

KWQ

Device Class

Class II

Regulation

21 CFR Part 888.3060

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 →