FDA 510(k) Applications for Medical Device Product Code "OVE"

FDA 510(k) Number Applicant Device Name Decision Date
K190870 4Web, Inc. Cervical Spinal Truss System-Stand Alone (CSTS-SA) 08/12/2019
K153629 Aesculap Implant Systems, Inc. ArcadiusXP C Spinal System 05/25/2016
K152972 AMENDIA, INC. Amendia Stand-Alone Cervical System 01/14/2016
K101588 APOLLO SPINE, INC. ECLIPSE VERTEBRAL SPACER SYSTEM-CERVICAL 01/07/2011
K152622 BIOMET SPINE Alta ACDF System 07/08/2016
K151064 BIOMET SPINE Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small Intervertebral Body Fusion System 08/12/2015
K120819 CENTINEL SPINE, INC. STALIF C 08/31/2012
K133200 CENTINEL SPINE, INC. STALIF C(R) 05/08/2014
K150053 Centinel Spine, Inc. STALIF C; STALIF C-Ti 06/24/2015
K142079 CENTINEL SPINE, INC. STALIF CTI, STALIF C 10/24/2014
K152515 CHOICE SPINE, LP TOMCAT Cervical Spinal System 12/18/2015
K170953 Choice Spine, LP Tomcat Cervical Spinal System 04/21/2017
K171489 Choice Spine, LP. Acapella Cervical Spacer System 10/23/2017
K182151 CTL Medical Corporation MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate 10/11/2018
K113796 EBI, LLC SOLITAIRE-C CERVICAL SPACER SYSTEM 04/26/2012
K190885 Elevation Spine Elevation Spine Saber-C System 08/07/2019
K132582 EXACTECH, INC. EXACTECH ACAPELLA ONE CERVICAL SPACER SYSTEM 02/12/2014
K180056 Genesys Spine Genesys Spine AIS-C Cervical Anchored Interbody System 03/28/2018
K181295 Genesys Spine Genesys Spine AIS-C Cervical Stand-Alone System 08/29/2018
K152099 GENESYS SPINE Genesys Spine Apache« Anchored Cervical Interbody Fusion System 07/28/2016
K083389 GLOBUS MEDICAL INC. COALITION SPACER 03/26/2009
K151939 GLOBUS MEDICAL INC. COALITION Spacers 01/29/2016
K131449 GLOBUS MEDICAL, INC. COALITION SPACER 07/30/2013
K150913 INCITE INNOVATION INCITE ANCHORED CERVICAL INTERBODY DEVICE 04/30/2015
K122008 INCITE INNOVATION LLC INCITE ANCHORED CERVICAL INTERBODY (ACI) FUSION DEVICE 11/16/2012
K130306 INCITE INNOVATION LLC INCITE ANCHORED CERVICAL INTERBODY DEVICE 04/11/2013
K111439 K2M, INC. CHESAPEAKE (CERVICAL COMPONENTS) 08/24/2011
K112388 LANx, Inc LANX CERVICAL SA 12/16/2011
K150765 LDR SPINE USA LDR Spine ROI-C Cervical Cage System 09/17/2015
K151934 LDR SPINE USA ROI-C Titanium-Coated Implant System 12/07/2015
K180642 Life Spine Inc. Pro-Link« Ti Stand-Alone Cervical Spacer System 05/10/2018
K121151 LIFE SPINE, INC PRO-LINK CERVICAL SPACER SYSTEM 11/16/2012
K160066 Life Spine, Inc. Pro-Link« Stand-Alone Cervical Spacer System 09/02/2016
K094042 MEDTRONIC SOFAMOR DANEK PEEK PREVAIL CERVICAL INTERBODY DEVICE 06/30/2010
K113252 MEDTRONIC SOFAMOR DANEK PEEK PREVAIL CERVICAL INTERBODY DEVICE 01/17/2012
K141599 MEDTRONIC SOFAMOR DANEK USA, INC. DIVERGENCE ANTERIOR CERVICAL FUSION SYSTEM 01/21/2015
K073285 MEDTRONIC SOFAMOR DANEK USA, INC. PEEK PREVAIL CERVICAL INTERBODY DEVICE 05/15/2008
K173077 NeuroStructures, Inc. Cavetto-SA Cervical Cage System 02/23/2018
K181621 Nexus Spine, LLC Stable-C Interbody System 10/19/2018
K190546 Nexxt Spine LLC NEXXT MATRIXX Stand Alone Cervical System 05/31/2019
K161442 NUVASIVE INCORPORATED NuVasive« CoRoent« Small InterlockÖ System 09/28/2016
K102547 NUVASIVE, INC. COROENT INTERLOCK SYSTEM 02/07/2011
K142299 NUVASIVE, INCORPORATED CoRoent Small Interlock System 11/25/2014
K170961 NuVasive, Incorporated NuVasive CoRoent Small Interlock II System 06/08/2017
K132999 ORTHOFIX INC. CERVICAL STAND ALONE SYSTEM 04/14/2014
K161280 Orthofix Inc. Cervical Stand Alone System 06/17/2016
K170830 Pioneer Surgical Technology, Inc. DBA RTI Surgical, Inc. Unison-C Anterior Cervical Fixation System 06/28/2017
K152793 PIONEER SURGICAL TECHNOLOGY,INC. DBA RTI SURGICAL, INC. Unison-C Anterior Cervical Fixation System 01/19/2016
K163474 PROVIDENCE MEDICAL TECHNOLOGY, INC. CAVUX CervicalCage-L SA System 03/10/2017
K153250 RENOVIS SURGICAL TECHNOLOGIES Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System 03/16/2016
K111272 RHAUSLER, INC. RHAUSLER PLAGE ANTERIOR CERVICAL FUSION SYSTEM 11/29/2011
K081194 RSB SPINE LLC. INTERPLATE PEEK CERVICAL INTERBODY FUSION DEVICE (IFD) 05/29/2008
K162531 SAFE ORTHOPAEDICS STERISPINE CC 12/29/2016
K161081 SEASPINE ORTHOPEDICS CORPORATION SeaSpine Shoreline ACS - Anterior Cervical Standalone System 09/14/2016
K170569 SeaSpine Orthopedics Corporation SeaSpine Shoreline ACS - Anterior Cervical Standalone System 06/15/2017
K190655 SeaSpine Orthopedics Corporation SeaSpine« ShorelineÖ ACS- Anterior Cervical Standalone System 04/29/2019
K092521 SEASPINE, INC. ZUMA-C 04/13/2010
K153352 Spinal Elements Inc. Vertu« & Vertu« Ti-Bond and Crystal« & Crystal« Ti-Bond Cervical Interbody System 08/01/2016
K133218 SPINAL ELEMENTS, INC. Crystal «; Mosaic «; Vertu « 12/10/2014
K071833 SPINAL ELEMENTS, INC. MOSAIC DEVICES 10/23/2007
K122771 SPINAL ELEMENTS, INC. SPINAL ELEMENTS CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM 01/10/2013
K132029 SPINAL USA VAULT-C INTERVERTEBRAL BODY FUSION DEVICE 11/25/2013
K122630 SPINE SMITH PARTNERS L.P. IN:C2 SPINAL FIXATION SYSTEM 12/05/2012
K173175 Spine Wave, Inc. Paramount Anterior Cervical Cage System 11/01/2017
K162760 SPINE WAVE, INC. Spine Wave Anterior Cervical Spine System 02/16/2017
K141314 SPINEART SCARLET AC-T SECURED ANTERIOR CERVICAL CAGE AND ASSOCIATED INSTRUMENTATION 09/29/2014
K143214 SPINEART SCARLET« AC-T Secured Anterior Cervical Cage 02/23/2015
K172484 SpineFrontier, Inc. A-CIFT SoloFuse 05/08/2018
K151198 SPINEFRONTIER, INC. A-CIFT SoloFuse 07/17/2015
K131880 SPINEFRONTIER, INC. SPINEFRONTIER A-CIFT SOLOFUSE CERVICAL INTERVERTEBRAL FUSION DEVICE SYSTEM 01/03/2014
K141537 SPINESMITH HOLDINGS, LLC IN:C2 SPINAL FIXATION SYSTME 11/25/2014
K102606 STRYKER SPINE AVS ANCHOR-C CERVICAL CAGE SYSTEM 04/22/2011
K072415 SURGICRAFT LTD. STALIF (TM) C 01/25/2008
K093762 SYNTHES SPINE SYNTHES ZERO-P 12/20/2010
K072981 SYNTHES SPINE CO.LP SYNTHES ZERO-P 02/11/2008
K112459 SYNTHES SPINE CO.LP SYNTHES ZERO-P 12/12/2011
K121852 SYNTHES SPINE CO.LP SYNTHES ZERO-P VARIABLE ANGLE (VA) 07/25/2012
K112068 SYNTHES SPINE CO.LP SYNTHES ZERO-P VARIABLE ANGLE (VA) 11/07/2011
K102323 THEKEN SPINE LLC CERVICAL STANDALONE INTERVERTEBRAL BODY FUSION DEVICE 12/16/2010
K191565 Titan Spine, Inc Endoskeleton TCS Interbody Fusion Device 08/06/2019
K151596 TITAN SPINE, LLC Endoskeleton TCS Interbody Fusion Device 10/09/2015
K142940 TITAN SPINE, LLC Endoskeleton TCS System 01/28/2015
K153122 TITAN SPINE, LLC Endoskeleton(r) TCS System 12/14/2015
K172424 U&I Corporation VelofixÖ SA Cervical Cage 11/22/2017
K131951 X-SPINE SYSTEMS, INC. IRIX-C CERVICAL INTEGRATED FUSION SYSTEM 08/14/2013
K162944 X-SPINE SYSTEMS, INC. Irix-C Cervical Integrated Fusion System 11/07/2016
K160313 XENCO MEDICAL, LLC Xenco Medical Cervical Interbody System 10/21/2016
K141005 ZAVATION, LLC Z-LINK CERVICAL 08/07/2014
K132894 ZIMMER SPINE, INC. OPTIO-C ANTERIOR CERVICAL SYSTEM 01/16/2014


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