FDA 510(k) Applications Submitted by ZIMMER SPINE, INC.

FDA 510(k) Number Submission Date Device Name Applicant
K121671 06/06/2012 PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM ZIMMER SPINE, INC.
K132894 09/16/2013 OPTIO-C ANTERIOR CERVICAL SYSTEM ZIMMER SPINE, INC.
K140611 03/10/2014 TRINICA ANTERIOR LUMBAR PLATE SYSTEM ZIMMER SPINE, INC.
K141500 06/06/2014 OPTIO-C ANTERIOR CERVICAL SYSTEM ZIMMER SPINE, INC.
K150896 04/02/2015 Vitality Spinal Fixation System ZIMMER SPINE, INC.
K142752 09/24/2014 Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation System, Nex-Link OCT Cervical Plating System, Sequoia Pedicle Screw System including SpeedLink II, ST360║ Spinal Fixatoin System, Title 2 Polyaxial Spinal System ZIMMER SPINE, INC.
K143297 11/17/2014 Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody Fusion System, InFix Anterior Lumbar System, TraXis Vertebral Body Replacement (Ti and VUE) Zimmer Spine, Inc.
K143626 12/22/2014 inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical Plating System, SC-AcuFix Slimline Anterior Cervical Plate System, SC-AcuFix Thinline Anterior Cervical Plate System, Trinica Anterior Lumbar Plate System, Trinica and Trinica Sele Zimmer Spine, Inc.
K111796 06/27/2011 INVIZIA ANTERIOR CERVICAL PLATE SYSTEM ZIMMER SPINE, INC.
K080367 02/12/2008 ZIMMER MIS LIGHT ZIMMER SPINE, INC.
K142053 07/29/2014 UNIVERSAL CLAMP SPINAL FIXATION SYSTEM ZIMMER SPINE, INC.
K133556 11/19/2013 VIRAGE OCT SPINAL FIXATION SYSTEM ZIMMER SPINE, INC.
K131980 06/28/2013 SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM ZIMMER SPINE, INC.
K132012 07/01/2013 TRINICA(R) ANTERIOR CERVICAL PLATE SYSTEM, TRINICA(R) SELECT ANTERIOR CERVICAL PLATE SYSTEM ZIMMER SPINE, INC.
K132884 09/13/2013 PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM ZIMMER SPINE, INC.
K041925 07/19/2004 ST360 SPINAL FIXATION SYSTEM ZIMMER SPINE, INC.
K133086 09/30/2013 TITLE 2 POLYAXIAL SPINAL SYSTEM ZIMMER SPINE, INC.
K061353 05/15/2006 TRINICA ANTERIOR LUMBAR PLATE SYSTEM ZIMMER SPINE, INC.
K101704 06/17/2010 ZIMMER DTO PIN PRESS INSTRUMENT ZIMMER SPINE, INC.
K072183 08/06/2007 ST360 SPINAL FIXATION SYSTEM, MODEL 07.0029-7500.5600 ZIMMER SPINE, INC.
K042702 09/30/2004 SILHOUETTE SPINAL FIXATION SYSTEM ZIMMER SPINE, INC.


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