Synthes Zero-P

• • Terminated Z-0104-2012 FDA Unclassified (pre-2012) ·initiated 23 Sep 2011 ·via K072981, on the same 510(k)

  LABELING CORRECTION - Following review of labeling and promotional materials associated with the Zero-P Implant system, it was found that the materials reference a study where PEEK-CR is utilized as a cervical interbody spacer. PEEK-CR is not currently indicated for use as a cervical interbody spacer.

• • Terminated Z-1348-2009 FDA Unclassified (pre-2012) ·initiated 10 Feb 2009 ·via K072981, on the same 510(k)

  Tip breakage, due to inadequate instructions for use. The Technique Guide provided incorrect information related to use of the Torque Limiting Attachment during screw insertion and final tightening.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

510(k) Number

K072981 ↗

FDA Product Code

OVE

Device Class

Class II

Regulation

21 CFR Part 888.3080

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Synthes Zero-P

  Class II

  FDA 510(k) K112459 Active Cleared 12 Dec 2011

• Synthes Antegra System

  Class II

  FDA 510(k) K063158 Active Cleared 14 Nov 2006

• Synex Ii

  Class II

  FDA 510(k) K061891 Active Cleared 18 Aug 2006

• Synfix -Lr

  Class II

  FDA 510(k) K062083 Active Cleared 3 Apr 2007

• Synthes Oc Fusion and Synapse Systems

  Class II

  FDA 510(k) K072434 Active Cleared 10 Jan 2008

• Synthes Zero-P Variable Angle (VA)

  Class II

  FDA 510(k) K112068 Active Cleared 7 Nov 2011

See all devices from Synthes Spine Co.Lp →