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

FDA 510(k) Number Applicant Device Name Decision Date
K100802 AESCULAP IMPLANT SYSTEMS, INC. AESCULAP IMPLANT SYSTEMS SIBD SPINAL SYSTEM 07/20/2010
K111122 AESCULAP IMPLANT SYSTEMS, INC. AESCULAP SIBD XP SPINAL SYSTEM 08/04/2011
K102402 ALPHATEC SPINE, INC. SOLUS ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SPINAL SPACER SYSTEM 03/30/2011
K123993 ALPHATEC SPINE, INC. SOLUS ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM 03/05/2013
K160291 Amendia, Inc. Optimus ALIF System 02/18/2016
K102121 APOLLO SPINE, INC. ECLIPSE VERTEBRAL SPACER SYSTEM-LUMBAR 01/12/2011
K130641 BINDER BIOMEDICAL, INC LOGIC STAND-ALONE INTERVERTEBRAL BODY FUSION DEVICE 09/13/2013
K141798 BIOGENNIX, LLC SYPHER SPACER SYSTEM 02/19/2015
K141791 BIOMET SPINE BIOMET FUSION SYSTEM 10/09/2014
K093629 BIOMET SPINE SOLITAIRE AND SOLITAIRE PEEK ANTERIOR SPINAL SYSTEM 03/09/2010
K081501 BIOMET SPINE SOLITAIRE ANTERIOR SPINAL SYSTEM 07/02/2008
K081395 BIOMET SPINE SOLITAIRE PEEK-OPTIMA ANTERIOR SPINAL SYSTEM 06/25/2008
K120557 BIOMET SPINE & BONE HEALING TECHNOLOGIES SOLITARIE PEEK ANTERIOR SPINAL SYSTEM-TO BE CALLED COLITAIRE 35 03/19/2012
K081849 BLACKSTONE MEDICAL, INC. BLACKSTONE PILLAR SA PARTIAL VERTEBRAL BODY REPLACEMENT DEVICE 08/28/2008
K153720 Camber Spine Technologies ENZA Zero-Profile Anterior Interbody Fusion 05/03/2016
K173432 Camber Spine Technologies ENZA-A Titanium ALIF 04/18/2018
K130461 CENTINEL SPINE INC. STALIF X 08/28/2013
K150643 CENTINEL SPINE, INC. Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti 06/08/2015
K133286 CENTINEL SPINE, INC. MIDLINE (TM) 01/09/2014
K141942 CENTINEL SPINE, INC. MIDLINE II TI 11/07/2014
K180519 Choice Spine, LP HARRIER-SAÖ Lumbar Interbody System 05/16/2018
K172083 CLARIANCE SAS IdysÖ ALIF System 11/08/2017
K180814 CoreLink, LLC CoreLink« M3Ö Stand-Alone Anterior Lumbar System 08/10/2018
K132596 CUSTOM SPINE, INC. PROPOSED OPTIMUS 04/11/2014
K180695 FBC Device ApS FBC 921 (ALIF) 07/12/2018
K143228 FRONTIER MEDICAL DEVICES, INC. Ancora LLC Interbody Fusion Device 02/26/2015
K112700 FRONTIER MEDICAL DEVICES, INC. FRONTIER SADL INTERBODY FUSION DEVICE 11/01/2012
K160597 GLOBUS MEDICAL INC. INDEPENDENCE MIS Spacers 08/29/2016
K120101 GLOBUS MEDICAL INC. INDEPENDENCE SPACER 03/27/2012
K170157 Globus Medical Inc. INDEPENDENCE« Spacers 09/25/2017
K103382 GLOBUS MEDICAL INC. INTERCONTINENTAL PLATE-SPACER 05/20/2011
K142498 GLOBUS MEDICAL INC. MAGNIFY and MAGNIFY-S Spacers 02/26/2015
K132559 GLOBUS MEDICAL INC. MONUMENT SPACERS 12/30/2013
K161223 GLOBUS MEDICAL INC. TransContinental« M Spacers and InterContinental« Plate-Spacers 07/15/2016
K161379 GLOBUS MEDICAL, INC. ELSA Spacers 09/29/2016
K082252 GLOBUS MEDICAL, INC. INDEPENDENCE SPACER 11/05/2008
K100516 GS MEDICAL CO., LTD. ANYPLUS PEEK CAGES 12/03/2010
K093808 INCITE INNOVATION LLC INCITE INNOVATION STAND ALONE INTERBODY FUSION DEVICE 03/24/2010
K162236 INNOVASIS, INC. Ax Stand-Alone ALIF System 04/20/2017
K172941 K2M CASCADIA Interbody System 02/12/2018
K142487 K2M Inc. Chesapeake Stabilization System 05/07/2015
K151481 K2M, INC Sahara Stabilization System 12/21/2015
K133494 K2M, INC. CHESAPEAKE SPINAL SYSTEM 06/10/2014
K120031 K2M, INC. CHESAPEAKE SPINAL SYSTEM 03/16/2012
K092211 K2M, INC. CHESAPEAKE SPINAL SYSTEM 03/05/2010
K131547 LANX, INC. LANX FUSION SYSTEM 07/12/2013
K123767 LANX, INC. LANX FUSION SYSTEM- SA 03/18/2013
K102738 LANX, LLC LANX FUSION SYSTEM 02/10/2011
K110327 LDR SPINE USA LDR SPINE ROI-A INTERBODY FUSION SYSTEM 09/30/2011
K142645 LDR SPINE USA INC. Avenue T TLIF Cage 06/11/2015
K113285 LDR SPINE USA INC. LDR SPINE USA AVENUE L INTERBODY FUSION 07/26/2012
K161173 LDR SPINE USA, INC. Avenue« T TLIF Cage 09/28/2016
K091301 LIFE SPINE LIFE SPINE STAND-ALONE SPACER SYSTEM 12/15/2009
K180215 Life Spine Inc. DYNA-LINK ELITE Stand-Alone Anterior Lumbar System 09/13/2018
K124034 MEDACTA INTERNATIONAL MECTALIF ANTERIOR 05/17/2013
K160605 MEDACTA INTERNATIONAL MectaLIF Anterior Stand-Alone 07/21/2016
K170455 Medacta International SA MectaLIF Anterior Stand Alone 03/16/2017
K141187 MEDICREA INTERNATIONAL S.A. IMPIX ALIF S/A 01/15/2015
K091813 MEDTRONIC SOFAMOR DANEK INTREPID SPINAL SYSTEM 11/17/2009
K121982 MEDTRONIC SOFAMOR DANEK SOVEREIGN SPINAL SYSTEM 07/26/2012
K172328 Medtronic Sofamor Danek SOVEREIGNÖ Spinal System 11/02/2017
K162680 MEDTRONIC SOFAMOR DANEK USA, INC. SOVEREIGN« Spinal System 12/14/2016
K110063 MEDTRONIC SOFAMOR DANEK, INC. SOVEREIGN SPINAL SYSTEM 10/04/2011
K173082 NeuroStructures, Inc. ArcoÖ-SA Lumbar Cage System 03/29/2018
K182195 NeuroStructures, Inc. ArcoÖ-SA Lumbar Cage System 11/09/2018
K152943 NUVASIVE INCORPORATED NuVasive Foundation-LL System 12/01/2015
K123045 NUVASIVE, INC. BRIGADE STANDALONE SYSTEM 04/16/2013
K131723 NUVASIVE, INC. COROENT SINGLE TAB SYSTEM 09/20/2013
K100043 NUVASIVE, INC. COROENT XLR STANDALONE SYSTEM 06/16/2010
K112561 NUVASIVE, INC. NUVASIVE COROENT NO-PROFILE SYSTEM 03/13/2012
K151214 NuVasive, Incorporated ALIF Interfixated System 06/25/2015
K140479 NUVASIVE, INCORPORATED COROENT XL-F SYSTEM 07/28/2014
K170592 NuVasive, Incorporated NuVasive BASE Interfixated Titanium System 04/26/2017
K181386 NuVasive, Incorporated NuVasive Brigade Lateral System 08/24/2018
K160051 NuVasive, Incorporated NuVasive« Interfixated Interbody System 04/20/2016
K161129 ORTHOFIX INC. PILLAR SA PTC 09/08/2016
K133827 OSTEO VASIVE LLC A-LINK Z 11/17/2014
K181118 Reliance Medical Systems Reliance Lumbar IBF System 01/09/2019
K182007 Renovis Surgical Technologies Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System 12/07/2018
K180502 Renovis Surgical Technologies Inc. S128 Anterior Lumbar Interbody Fusion (ALIF) System 06/14/2018
K142095 Renovis Surgical Technologies, Inc. RENOVIS S134 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM 10/15/2014
K140106 Renovis Surgical Technologies, Inc. S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM 03/27/2014
K131122 RENOVIS SURGICAL TECHNOLOGIES, LLC S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM 09/18/2013
K071922 RSB SPINE LLC. INTERPLATE INTERBODY FUSION DEVICE, MODELS C, CGC, L AND LGC 09/18/2007
K173606 SeaSpine Orthopedics Corporation SeaSpine Vu aòPOD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu aòPOD Prime Intervertebral Body Fusion Device 04/13/2018
K162351 SEASPINE ORTHOPEDICS CORPORATION SeaSpine« Vu aòPODÖ Prime NanoMetalene« Intervertebral Body Fusion Device 12/01/2016
K082926 SEASPINE, INC. ZUMA, MODEL 55-XXXX/56-XXXX 12/22/2008
K170855 SIATS, LLC T-Rex Standalone ALIF 09/07/2017
K172019 Signature Orthopaedics Pty Ltd. Brisbane ALIF Device, Gladstone ALIF Device 11/29/2017
K083475 SPINAL ELEMENTS, INC. LUCENT MAGNUM 02/13/2009
K081711 SPINAL ELEMENTS, INC. LUCENT MAGNUM+ 09/11/2008
K130445 SPINAL USA VAULT ALIF SYSTEM 04/25/2013
K103369 SPINAL USA VAULT ALIF SYSTEM 04/04/2011
K102090 SPINE SMITH PARTNERS L.P. SPINESMITH CYNCH SPINAL SYSTEM - VISUALIF INTERBODY FUSION IMPLANT SYSTEM 09/30/2010
K122168 SPINE SMITH PARTNERS L.P. VISUALIF CHALLENGING ACCESS PLATE 10/11/2012
K161993 Spine Wave, Inc. Leva« Anterior Interbody System 11/22/2016
K181818 Spineart Scarlet AL-T 10/09/2018
K180002 Spineology Inc. Rampart One Lumbar Interbody Fusion Device 04/25/2018
K163670 SPINEOLOGY INC. Rampart One Lumbar Interbody Fusion Device 05/08/2017
K133328 STRYKER CORPORATION AERO-AL LUMBAR CAGE SYSTEM 05/30/2014
K142066 STRYKER CORPORATION AERO-LL LUMBAR CAGE SYSTEM 11/13/2014
K143163 STRYKER CORPORATION AVS« AL and ALign PEEK Spacers, AVS« PL and UniLIF PEEK Spacers, AVS« TL PEEK Spacer, AVS« Navigator PEEK Spacer, AVS« ARIA PEEK Spacer, AccuLIF TL and PL Cage, AVS« Anchor-L Spacer, Aero-AL Lumbar Cage System 01/26/2015
K120869 STRYKER SPINE ANCHOR-L LUMBAR CAGE 10/25/2012
K073109 SURGICRAFT LTD. STALIF TT INTERVERTEBRAL BODY FUSION SYSTEM 06/04/2008
K131276 SYNTHES (USA) PRODUCTS LLC LATERAL SYNFIX 01/06/2014
K150673 SYNTHES (USA) PRODUCTS LLC SYNFIX Evolution Secured Spacer System 08/21/2015
K072253 SYNTHES SPINE CO.LP SYNFIX-LR SPACER 10/12/2007
K080822 THEKEN SPINE LLC VU APOD INTERVERTABRAL BODY FUSION DEVICE 07/02/2008
K101310 THEKEN SPINE LLC VU APOD INTERVERTEBRAL BODY FUSION DEVICE 09/02/2010
K121211 THEKEN SPINE, LLC VU APOD INTERVERTEBRAL BODY FUSION DEVICE 06/27/2012
K111626 TITAN SPINE, LLC ENDOSKELETON(R) TAS 09/09/2011
K163269 TITAN SPINE, LLC Endoskeleton(R) TAS Interbody Fusion Device / Endoskeleton(R) TAS Hyperlordotic Interbody Fusion Device 04/13/2017
K151312 VGI, LLC VerteLP Interbody Fusion Device 01/13/2016
K133947 X-SPINE SYSTEMS, INC IRIX-A LUMBAR INTEGRATED FUSION SYSTEM 07/29/2014
K171567 X-Spine Systems, Inc. IRIX-A Lumbar Integrated Fusion System 08/28/2017
K142271 Zavation, LLC Zavation Z-Link Lumbar 12/19/2014
K163543 Zimmer Biomet Spine Inc. Biomet Fusion System 02/28/2017
K181096 Zimmer Biomet Spine, Inc. Avenue P Cage System 01/15/2019


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