FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K200002 |
4Web, Inc. |
Anterior Spine Truss System û Stand Alone (ASTS-SA) Interbody Fusion Device |
05/29/2020 |
K201671 |
Acuity Surgical Devices, LLC |
A-Link Z |
05/04/2021 |
K222561 |
Acuity Surgical Devices, LLC |
Align |
09/23/2022 |
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 |
K203742 |
Alphatec Spine Inc. |
IdentiTi ALIF Standalone Interbody System |
04/09/2021 |
K232097 |
Alphatec Spine, Inc. |
IdentiTi ALIF Interbody Systems |
09/25/2023 |
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 |
K211837 |
Altus Partners, LLC |
Altus Spine Interbody Standalone Fusion System |
04/19/2022 |
K160291 |
Amendia, Inc. |
Optimus ALIF System |
02/18/2016 |
K102121 |
APOLLO SPINE, INC. |
ECLIPSE VERTEBRAL SPACER SYSTEM-LUMBAR |
01/12/2011 |
K222554 |
Astura Medical |
EL CAPITAN Anterior Lumbar Interbody Fusion |
01/19/2023 |
K214047 |
Astura Medical |
EL CAPITAN Anterior Lumbar Interbody Fusion System |
03/30/2022 |
K192492 |
Astura Medical, LLC |
EL CAPITAN Anterior Lumber Interbody System |
04/21/2020 |
K220610 |
Aurora Spine Inc |
SOLO-L |
05/27/2022 |
K200352 |
Axis Spine Technologies Ltd |
Axis Spine Technologies ALIF |
05/20/2020 |
K210590 |
Axis Spine Technologies Ltd |
Axis Spine Technologies ALIF |
09/29/2021 |
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 |
K221324 |
Camber Spine Technologies |
ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF) |
03/30/2023 |
K222009 |
Carlsmed, Inc. |
aprevo« anterior lumbar interbody fusion device with interfixation |
11/22/2022 |
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 |
K191263 |
Clariance SAS |
Idys ALIF TiVac |
06/06/2019 |
K172083 |
CLARIANCE SAS |
IdysÖ ALIF System |
11/08/2017 |
K192168 |
CLARIANCE, SAS |
Idys ALIF ZP 3DTi |
11/04/2019 |
K202032 |
Clariance, SAS |
Idys LLIF 3DTi |
04/01/2021 |
K180814 |
CoreLink, LLC |
CoreLink« M3Ö Stand-Alone Anterior Lumbar System |
08/10/2018 |
K132596 |
CUSTOM SPINE, INC. |
PROPOSED OPTIMUS |
04/11/2014 |
K221936 |
Eminent Spine |
Standalone ALIF Interbody Fusion System |
10/17/2022 |
K223146 |
Evolution Spine |
EVOLUTION SPINE Interbody System |
02/07/2023 |
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 |
K201087 |
Globus Medical, Inc. |
CORBEL Spacers |
07/31/2020 |
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 |
K200541 |
HD LifeSciences LLC |
HiveÖ Stand-alone Anterior Lumbar Interbody System |
04/28/2020 |
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 |
K182139 |
Innovasis, Inc. |
AXTi Titanium Stand-Alone ALIF System |
06/21/2019 |
K212967 |
Innovasis, Inc. |
AxTiHA Stand-Alone ALIF System |
10/15/2021 |
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 |
K190179 |
K2M, Inc. |
SAHARA Stabilization System |
10/03/2019 |
K193320 |
Kyocera Medical Technologies, Inc. |
KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) System |
02/04/2020 |
K230808 |
Kyocera Medical Technologies, Inc. |
PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System |
04/21/2023 |
K212980 |
Kyocera Medical Technologies, Inc. |
Tesera-k ALIF System |
01/07/2022 |
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 |
K200338 |
Life Spine Inc. |
ProLift Lateral Fixated |
04/17/2020 |
K191834 |
Life Spine Inc. |
Stand-Alone ALIF Titanium System |
12/16/2019 |
K124034 |
MEDACTA INTERNATIONAL |
MECTALIF ANTERIOR |
05/17/2013 |
K160605 |
MEDACTA INTERNATIONAL |
MectaLIF Anterior Stand-Alone |
07/21/2016 |
K221545 |
Medacta International S.A. |
MectaLIF Anterior Extension |
10/24/2022 |
K170455 |
Medacta International SA |
MectaLIF Anterior Stand Alone |
03/16/2017 |
K183426 |
Medacta International SA |
MectaLIF Anterior Stand Alone Extension |
03/15/2019 |
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 USA, INC |
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 |
K220115 |
MiRus, LLC |
ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion System |
05/13/2022 |
K232154 |
MiRus, LLC |
MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation |
09/11/2023 |
K202190 |
Neurostructures |
Oculus-SA Lumbar Cage System |
10/02/2020 |
K173082 |
NeuroStructures, Inc. |
ArcoÖ-SA Lumbar Cage System |
03/29/2018 |
K182195 |
NeuroStructures, Inc. |
ArcoÖ-SA Lumbar Cage System |
11/09/2018 |
K212498 |
Nexus Spine, LLC |
Stable-L Standalone Lumbar Interbody System |
03/18/2022 |
K232530 |
Nexus Spine, LLC |
Stable-L Standalone Lumbar Interbody System, Stable-C Interbody System |
09/18/2023 |
K202230 |
Nexxt Spine LLC |
NEXXT MATRIXX Stand Alone ALIF System |
12/15/2020 |
K211769 |
NovApproach Spine |
OneLIF Intervertebral Body Replacement System |
09/07/2021 |
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 |
K193593 |
NuVasive, Incorporated |
NuVasive 3DP Interfixated ALIF System |
03/25/2020 |
K170592 |
NuVasive, Incorporated |
NuVasive BASE Interfixated Titanium System |
04/26/2017 |
K181386 |
NuVasive, Incorporated |
NuVasive Brigade Lateral System |
08/24/2018 |
K221751 |
NuVasive, Incorporated |
NuVasive Cohere ALIF System Intervertebral Body Fusion Device |
10/21/2022 |
K230894 |
NuVasive, Incorporated |
NuVasive Modulus ALIF System |
06/16/2023 |
K210271 |
NuVasive, Incorporated |
NuVasive Modulus ALIF System |
03/01/2021 |
K160051 |
NuVasive, Incorporated |
NuVasive« Interfixated Interbody System |
04/20/2016 |
K203207 |
Omnia Medical, LLC |
Omnia Medical TiBrid-SA |
12/23/2020 |
K161129 |
ORTHOFIX INC. |
PILLAR SA PTC |
09/08/2016 |
K213935 |
Osseus Fusion Systems |
PISCES-SA Standalone ALIF Interbody System |
05/06/2022 |
K223413 |
Osseus Fusion Systems |
PiscesÖ-SA STANDALONE ALIF Interbody System |
02/10/2023 |
K133827 |
OSTEO VASIVE LLC |
A-LINK Z |
11/17/2014 |
K213118 |
Precision Spine, Inc. |
Dakota ALIF System |
04/01/2022 |
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 |
K221447 |
Southern Medical (Pty) Ltd |
Southern Anterior Screw Fixated Cage (SASCA) |
10/14/2022 |
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 |
K190877 |
SPINEART |
Juliet« Ti LL Lumbar Interbody Device |
05/29/2019 |
K192993 |
Spineart |
SCARLET AL-T |
01/22/2020 |
K181818 |
Spineart |
Scarlet AL-T |
10/09/2018 |
K163670 |
SPINEOLOGY INC. |
Rampart One Lumbar Interbody Fusion Device |
05/08/2017 |
K180002 |
Spineology Inc. |
Rampart One Lumbar Interbody Fusion Device |
04/25/2018 |
K191091 |
Spineology, Inc. |
Rampart One Lumbar Interbody Fusion System |
05/23/2019 |
K192047 |
Spineology, Inc. |
RampartÖ One Lumbar Interbody Fusion System |
08/23/2019 |
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 |
K201585 |
Stryker Corporation |
Monterey AL Interbody System |
08/10/2020 |
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 |
K192054 |
Titan Spine, Inc |
Endoskeleton TAS Plate |
08/29/2019 |
K191581 |
Titan Spine, Inc |
Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion Device |
01/08/2020 |
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 |
K230731 |
Zavation Medical Products, LLC |
Zavation ALIF System |
06/14/2023 |
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 |