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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