FDA 510(k) Applications for Medical Device Product Code "MAX"
(Intervertebral Fusion Device With Bone Graft, Lumbar)

FDA 510(k) Number Applicant Device Name Decision Date
K083894 4-WEB SPINE, LLC ALIF SPINAL TRUSS INTERBODY FUSION DEVICE 01/18/2011
K112316 4-WEB, INC. 4-WEB ALIF SPINAL TRUSS SYSTEM (STS) 12/14/2011
K211388 4WEB Medical, Inc. Lateral Spine Truss System (LSTS) Interbody Fusion Device 08/05/2021
K142112 4WEB, INC. 4WEB SPINAL IMPLANT PRODUCTS 09/23/2014
K170851 4Web, Inc. Anterior Spine Truss System (STS) Interbody Fusion Device 08/07/2017
K172392 4Web, Inc. Lateral Spinal Truss System (LSTS) Interbody Fusion Device 11/07/2017
K153436 4Web, Inc. LATERAL Spine Truss System 06/06/2016
K171351 4Web, Inc. Posterior Spine Truss System (PSTS) Interbody Fusion Device 09/08/2017
K143258 4WEB,INC. PLIF STS, TLIF STS, OLIF STS (Spinal Truss System) 04/09/2015
K073202 ABBOTT SPINE, INC. ARDIS SPACER 01/30/2008
K131981 ACCEL SPINE CEZANNE II INTERBODY FUSION SYSTEM 10/09/2013
K121567 ACCEL SPINE ORACLE LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM 09/26/2012
K221535 Acuity Surgical Devices, LLC Align Lumbar Interbody Fusion System 07/22/2022
K223065 Adcura, Inc. Adcura« Sagittae« Lateral Lumbar Interbody Fusion Devices 10/26/2022
K121288 ADVANCED MEDICAL TECHNOLOGIES AG FUSE CAGE 06/29/2012
K100945 ADVANCED MEDICAL TECHNOLOGIES AG FUSE PLIF CAFE 02/09/2011
K121332 ADVANCED MEDICAL TECHNOLOGIES AG LOOP CAGE 06/29/2012
K080401 ADVANCED MEDICAL TECHNOLOGIES AG SHELL CAGE, WAVE CAGE, LOOP CAGE 05/09/2008
K121333 ADVANCED MEDICAL TECHNOLOGIES AG WAVE D CAGE 06/29/2012
K121330 ADVANCED MEDICAL TECHNOLOGIES AG WAVE O CAGE 06/29/2012
K083626 ADVANCED MEDICAL TECHNOLOGY, INC. DISTRACTABLE WAVE CAGE 10/19/2009
K173947 Advanced Research Medical, LLC Lumbar Interbody Fusion System (OLLIF) 07/25/2018
K100037 ADVANCED VERTEBRAL SOLUTIONS, LLC ADVANCED VERTEBRAL SOLUTIONS EXPRESS BFD 09/23/2010
K221719 Aegis Spine, Inc. ABTross ALIF Expandable Cage System 11/03/2022
K203531 Aegis Spine, Inc. XYPAN Expandable Lumbar Cage System 01/29/2021
K071983 AESCULAP IMPLANT SYSTEMS, INC. AESCULAP PEEK INTERVERTEBRAL BODY FUSION SYSTEM: A SPACE, CESPACE, PROSPACE, T-SPACE 05/01/2008
K132421 AESCULAP IMPLANT SYSTEMS, INC. AESCULAP PEEK XP SPINAL IMPLANT SYSTEM 01/22/2014
K151056 AESCULAP IMPLANT SYSTEMS, LLC Aesculap T-Space PEEK and XP Spinal System 08/13/2015
K122047 ALLIANCE PARTNERS, LLC ALAMO P 09/04/2012
K120401 ALLIANCE PARTNERS, LLC ALAMO T 10/05/2012
K140303 ALLIANCE PARTNERS, LLC. ALAMO T 04/21/2014
K222028 Alphatec Spine IdentiTiÖ Porous Ti Interbody System, IdentiTiÖ NanoTecÖ Interbody System, TranscendÖ PEEK Interbody System, TranscendÖ NanoTecÖ Interbody System, IdentiTiÖ ALIF Standalone Interbody System, IdentiTiÖ NanoTecÖ ALIF Standalone Interbody System 10/07/2022
K160646 Alphatec Spine, Inc XYcor« Expandable Spinal Spacer System 08/24/2016
K182746 Alphatec Spine, Inc. ATEC ALIF and LLIF Spacer System 11/27/2018
K181453 Alphatec Spine, Inc. ATEC ALIF Spacer System 07/25/2018
K191311 Alphatec Spine, Inc. ATEC Lateral Interbody System 08/12/2019
K202587 Alphatec Spine, Inc. ATEC Lateral Interbody System 11/06/2020
K143740 ALPHATEC SPINE, INC. Battalion Universal Spacer System 05/22/2015
K222455 Alphatec Spine, Inc. Calibrate LTX Interbody System 11/18/2022
K223611 Alphatec Spine, Inc. Calibrate LTX Interbody System 03/29/2023
K231438 Alphatec Spine, Inc. Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody System 07/13/2023
K130548 ALPHATEC SPINE, INC. EPICAGE INTERBODY FUSION DEVICE 04/18/2013
K090425 ALPHATEC SPINE, INC. GUIDED LATERAL INTERBODY FUSION (GLIF) SYSTEM 05/19/2009
K183705 Alphatec Spine, Inc. IdentiTi Porous Ti Interbody System 03/01/2019
K211805 Alphatec Spine, Inc. IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec Interbody System, Transcend NanoTec Interbody System 09/22/2021
K220782 Alphatec Spine, Inc. IdentiTiÖ Porous Ti Interbody System, IdentiTiÖ NanoTecÖ Interbody System, TranscendÖ PEEK Interbody System, TranscendÖ NanoTecÖ Interbody System, IdentiTiÖ ALIF Standalone Interbody System, IdentiTiÖ NanoTecÖ ALIF Standalone Interbody System, IdentiTiÖ C 06/09/2022
K090782 ALPHATEC SPINE, INC. NOVEL ALIF SPINAL SPACER SYSTEM 04/22/2009
K211873 Alphatec Spine, Inc. PSX Interbody System 08/10/2021
K170553 Altus Partners, LLC Altus Spine Interbody Fusion System 12/01/2017
K182406 Altus Partners, LLC Altus Spine Interbody Fusion System 02/22/2019
K160976 ALTUS PARTNERS, LLC Altus Spine Interbody Fusion System 01/25/2017
K170512 Altus Partners, LLC Altus Spine Titanium Interbody Fusion System 03/10/2017
K171329 Altus Partners, LLC Altus Spine Titanium Interbody Fusion System 08/29/2017
K142347 Amedica Corp Amedica Valeo II Interbody Fusion Device 11/18/2014
K121892 AMEDICA CORP. PHANTOM PLUS CERAMIC CAGE SYSTEM 08/24/2012
K161405 AMEDICA CORP. Valeo II Interbody Fusion Device System 08/19/2016
K091278 AMEDICA CORP. VALEO SPACER SYSTEM 01/28/2010
K143518 Amedica Corp. Valeo Spacer System and Valeo II Interbody Fusion Device System 10/02/2015
K151310 AMENDIA, INC. Amendia Interbody Fusion Devices 01/06/2016
K151322 AMENDIA, INC. Amendia Interbody Fusion Devices 09/10/2015
K160924 AMENDIA, INC. Amendia Interbody Fusion Devices 11/08/2016
K150395 AMENDIA, INC. Omega LIF System 08/10/2015
K192434 Amplify Surgical Inc DualX Lumbar Intervertebral Body Fusion Device 10/15/2019
K211740 Amplify Surgical, Inc. DualX 09/29/2021
K222203 Amplify Surgical, Inc. DualXSLIM(R) T/PLIF 10/18/2022
K172947 Astura Medical HALF DOME Posterior Lumbar Interbody System 04/18/2018
K163481 Astura Medical HALF DOME Posterior Lumbar Interbody System 05/03/2017
K152512 Astura Medical Half Dome Posterior Lumbar Interbody System 01/28/2016
K223335 Astura Medical SIRION Lateral Lumbar Interbody System 05/09/2023
K182877 Astura Medical, LLC HALF DOME Posterior Lumbar Interbody System 05/03/2019
K202495 Astura Medical, LLC SIRION Lateral Lumbar Interbody Fusion 01/06/2021
K192006 Astura Medical, LLC SIRION Lateral Lumbar Interbody System 04/02/2020
K100743 ATLAS SPINE INC. ATLAS SPINE PIVOTING SYSTEM 08/10/2010
K162918 Atlas Spine, Inc. Atlas Spine Expandable Interbody System 02/09/2017
K172334 Atlas Spine, Inc. OrtusÖ Expandable Lumbar Interbody Fusion System 10/25/2017
K133967 AURORA SPINE INTERBODY CAGE SYSTEM 01/31/2014
K211474 Baat Medical Products BV Kleiner KG2 System 09/14/2021
K191353 BAUI Biotech Co., Ltd. COMET Lumbar Interbody Fusion Cage 04/14/2020
K183560 Benvenue Medical, Inc. Luna 3D GEN2 Interbody Fusion System 05/23/2019
K162431 Benvenue Medical, Inc. Luna 3D Interbody Fusion System 11/17/2016
K142023 BENVENUE MEDICAL, INC. LUNA INTERBODY SYSTEM 11/20/2014
K193172 Benvenue Medical, Inc. Luna XD Ti Interbody Fusion System 07/02/2020
K170890 Biedermann Motech GmbH & Co. KG TELIX K Interbody System 06/02/2017
K093015 BINDER BIOMEDICAL, INC BINDER INTERVERTEBRAL BODY FUSION DEVICE 02/25/2010
K181337 Biogennix, LLC Sypher Spacer System 09/18/2018
K081636 BIOMET SPINE PEEK-OPTIMA ALIF SPACER 08/07/2008
K112014 BIOMET SPINE ZYSTON STRAIGHT SPACER SYSTEM 10/17/2011
K122989 BIOMET SPINE (AKA EBI, LLC) BIOMET LATERAL SPACER SYSTEM 10/24/2012
K110650 BIOMET SPINE (AKA EBI, LLC) ZYSTON ARC INTERBODY SPACER 06/30/2011
K151483 Biomet Spine LLC. Biomet Spine Fusion System 07/31/2015
K153695 Biomet Spine LLC. Biomet Spine Fusion System 01/21/2016
K142634 BIOMET SPINE, LLC. Biomet Spine Fusion System 03/12/2015
K120464 BK MEDITECH CO., LTD. INNESIS PEEK CAGE 01/18/2013
K140577 BK MEDITECH CO., LTD. INNESIS PEEK TL CAGE 10/01/2014
K081177 BLACKSTONE MEDICAL, INC. BLACKSTONE MEDICAL, INC., PILLAR SPACER SYSTEM 07/23/2008
K082235 BLACKSTONE MEDICAL, INC. BLACKSTONE PILLAR XL PEEK SPACERS 09/04/2008
K171893 Bluestone Synergy Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone Synergy Cervical Interbody Fusion System (Slate) 09/08/2017
K082260 CALVARY SPINE LLC INTEGRA CERVICAL AND PETRA PLIF LUMBAR CAGES 10/17/2008
K134038 CAMBER SPINE CAMBER SPINE DIAGON OBLIQUE CAGE 03/20/2014
K121254 CAMBER SPINE TECHNOLOGIES CAMBER SPINE TECHNOLOGIES TLS 5.0 INERBODY CAGE 01/11/2013
K162986 CAMBER SPINE TECHNOLOGIES SPIRA Open Matrix ALIF 06/12/2017
K190483 Camber Spine Technologies SPIRA Open Matrix ALIF and LLIF 09/23/2019
K230942 Camber Spine Technologies SPIRA« Posterior Lumbar Spacers 07/11/2023
K172064 Camber Spine Technologies Ti-Diagon Oblique TLIF 09/15/2017
K180724 Camber Spine Technologies LLC SPIRA Open Matrix LLIF 06/25/2018
K210595 Camber Spine Technologies, LLC SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar Spacers 06/15/2021
K122956 CAPTIVA SPINE FUSELOX LUMBAR INTERBODY FUSION DEVICE 10/25/2012
K092017 CAPTIVA SPINE, INC PIVOTEC LUMBAR INTERBODY FUSION DEVICE (LIFD) 12/01/2009
K180990 Captiva Spine, Inc. TirboLOX-L Lumbar IBFD 08/13/2018
K193378 CarboFix Orthopedics Ltd. CarboClear Lumbar Cage System 03/02/2020
K203683 CarboFix Orthpedics Ltd. CarboClear Lumbar Cage System 01/15/2021
K202034 Carlsmed, Inc. aprevo Intervertebral Body Fusion Device 12/03/2020
K210542 Carlsmed, Inc. aprevo Transforaminal IBF 06/30/2021
K222082 Carlsmed, Inc. aprevo« anterior and lateral lumbar interbody fusion devices, aprevo« transforaminal lumbar interbody fusion devices 08/12/2022
K231140 Carlsmed, Inc. aprevo« transforaminal lumbar interbody fusion device 05/19/2023
K101301 CENTINEL SPINE STALIF MIDLINE 09/24/2010
K173347 Centinel Spine, Inc. STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX, ACTILIF M FLX, ACTILIF L FLX and ACTILIF Lateral-Oblique FLX 05/08/2018
K223776 Changzhou Geasure Medical Apparatus and Instruments Co., Ltd PEEK Spinal Infusion Cage 03/03/2023
K140142 CHOICE SPINE, LP CHOICE SPINE LUMBAR SPACER SYSTEM (SABRE, SHARK, HORNET, HARPOON) 07/16/2014
K162103 CHOICE SPINE, LP Choice Spine Lumbar Spacer System (SabreÖ, SharkÖ, HornetÖ, HarpoonÖ), Choice Spine Interbody Fusion System (HarrierÖ), Choice Spine Vertebral Body Replacement System (HawkeyeÖ) 11/23/2016
K153107 CHOICE SPINE, LP Choice Spine Lumbar Spacer System (SabreÖ, SharkÖ, HornetÖ, HarpoonÖ), Choice Spine VEOÖ Lateral Access & Interbody Fusion System, Choice Spine Interbody Fusion System 05/19/2016
K073669 CHOICE SPINE, LP ORIA NATURA SPACER 02/13/2008
K172816 Choice Spine, LP. TiGer SharkÖ System 01/26/2018
K191367 ChoiceSpine LLC Harrier-SA Lumbar Interbody System 07/05/2019
K220953 ChoiceSpine, LLC ChoiceSpine TigerSharkÖ M, Modular Interbody System 09/13/2022
K200919 CLARIANCE Idys ALIF 3DTi 04/12/2021
K131178 CLARIANCE IDYS LIF CAGES 10/10/2013
K183259 Clariance SAS IdysÖ TLIF TiVac 03/01/2019
K200920 Clariance, SAS Idys ALIF ZP 3DTi 05/29/2020
K172465 CLARIANCE, SAS IdysÖ TLIF 3DTi Cages 12/15/2017
K110270 COALIGN INNOVATIONS, INC. ACCULIF CAGE 04/07/2011
K123752 COALIGN INNOVATIONS, INC. ACCULIF TL AND PL CAGE 01/14/2013
K132505 COALIGN INNOVATIONS, INC. ACCULIF TL AND PL CAGE 09/12/2013
K113465 COALIGN INNOVATIONS, INC. ACCULIF TL CAGE 12/12/2011
K121683 COALIGN INNOVATIONS, INC. ACCULIF TL CAGE 07/05/2012
K123281 COALIGN INNOVATIONS, INC. ACCULIF TL-PEEK CAGE 01/23/2013
K112095 COALIGN INNOVATIONS, INC. ACCULIF TL-PEEK IBF CAGE 12/01/2011
K130194 COALIGN INNOVATIONS, INC. ACCULIF XL CAGE 04/03/2013
K131443 COALIGN INNOVATIONS, INC. COALIGN INNOVATIONS ACCULIF XL IBF CAGE 06/19/2013
K151406 COGENT SPINE LLC Cogent Lateral Interbody System 02/25/2016
K132738 COGENT SPINE LLC COGENT MED-LIF 04/15/2014
K142193 COGENT SPINE LLC COGENT MED-LIF XL 10/15/2014
K181963 coLigne, AG ostaPek Interbody Fusion Cages 11/14/2018
K073440 CORELINK LLC FOUNDATION CAGE 04/24/2008
K183239 Corelink, LLC CoreLink F3DÖ Lateral System 12/19/2018
K180556 Corelink, LLC Corelink Foundation 3D Anterior Lumbar System 07/27/2018
K151408 CORENTEC CO., LTD LOSPA IS Spinal System 10/02/2015
K170243 CORENTEC CO., LTD LOSPA IS TLIF & DLIF Cages 03/31/2017
K213641 CTL Medical Corporation MONDRIAN ALIF Cage with Supplementary Fixation Plate 09/15/2022
K192863 CTL Medical Corporation MONDRIAN Lumbar Interbody Fusion Cage System 08/26/2020
K231359 CTL Medical Corporation RODINÖ Expandable Lumbar Cage System 06/09/2023
K181589 Curiteva, LLC Curiteva Lumbar Interbody Fusion System 12/20/2018
K111774 CUSTOM SPINE PATHWAY MODEL 07XXXX 07/20/2011
K080281 CUSTOM SPINE, INC. PATHWAY 05/01/2008
K090566 CUSTOM SPINE, INC. PATHWAY AVID 06/01/2009
K111726 CUSTOM SPINE, INC. PATHWAY AVID 02/06/2012
K143143 CUSTOM SPINE, INC. PATHWAY ELIF 07/22/2015
K102957 CUTTING EDGE SPINE, LLC CUTTING EDGE SPINE INTERBODY FUSION DEVICE 04/28/2011
K192497 Cutting Edge Spine, LLC EVOL ha - D Lateral Interbody Fusion System 01/06/2020
K200991 Cutting Edge Spine, LLC EVOL Spinal Interbody System 05/13/2020
K180891 Cutting Edge Spine, LLC EVOL Spinal Interbody System, EVOS Lumbar Interbody System 05/04/2018
K150321 Cutting Edge Spine, LLC EVOS Lumbar Interbody System 07/13/2015
K200552 Cutting Edge Spine, LLC EVOS Lumbar Interbody System 04/02/2020
K223418 DeGen Medical DeGen Impulse AMÖ System 03/17/2023
K210090 DeGen Medical Impulse AM Interbody Fusion System 08/30/2021
K201287 DeGen Medical Impulse Interbody Fusion System 12/22/2020
K231199 DeGen Medical Solar Lumbar Interbody Fusion System 06/16/2023
K101923 DEPUY SPINE CONCORDE CURVE SYSTEM 12/01/2010
K082128 DEPUY SPINE DEPUY SPINE LATERAL CAGE SYSTEM 11/14/2008
K081917 DEPUY SPINE, INC. DEPUY SPINE BENGAL, CONCORDE, COUGAR, DEVEX AND LEOPARD SYSTEMS 05/22/2009
K090899 DEPUY SPINE, INC. DEPUY SPINE LATERAL SYSTEM 05/19/2009
K181231 DePuy Synthes Spine DePuy Synthes T-PAL Spacer System 12/06/2018
K131292 DEROYAL INDUSTRIES, INC. DEROYAL SPINE SPACER SYSTEM 02/03/2014
K100042 DIFUSION TECHNOLOGIES DIFUSION TECHNOLOGIES XIPHOS INTERBODY FUSION SYSTEM 10/01/2010
K190544 DiFusion Technologies XIHPOSÖ ZFUZEÖ Interbody Fusion System 11/01/2019
K123969 DIFUSION TECHNOLOGIES XIPHOS 02/07/2013
K172828 Double Medical Technology Inc Double Medical Cage System 02/01/2018
K092574 EBI, L.P. ESL SPINAL SYSTEM 02/04/2010
K082406 EBI, L.P. EXPANDABLE PEEK-OPTIMA IMPLANT 01/14/2009
K091381 EBI, L.P. IBEX SPINAL SYSTEM 08/07/2009
K140348 EISERTECH, LLC INTERBODY CAGE 04/23/2015
K113478 EISERTECH, LLC PLIF CAGE 03/05/2012
K201605 EIT Emerging Implant Technologies GmbH EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular Titanium TLIF Cage, EIT Cellular Titanium LLIF Cage, EIT Cellular Titanium T/PLIF Cage 07/15/2020
K170503 EIT Emerging Implant Technologies GmbH EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular Titanium TLIF Cages, and EIT Cellular Titanium ALIF Cages 07/11/2017
K183447 EIT Emerging Implant Technologies GmbH EIT Cellular Titanium Lumbar Cage - T/PLIF 02/04/2019
K172888 EIT Emerging Implant Technologies GmbH EIT Cellular Titanium« Cervical Cages, EIT Cellular Titanium« PLIF Cages, EIT Cellular Titanium« TLIF Cages, EIT Cellular Titanium« ALIF Cages 12/15/2017
K181644 EIT Emerging Implant Technologies GmbH EIT Cellular Titanium« Lumbar Cage LLIF 10/12/2018
K130274 ELITE SURGICAL SUPPLIES (PTY) LTD. BIOLIGN ACIF SYSTEMS, BIOLIGN STACC ACIF SYSTEM, BIOLIGN TLIF SYSTEM 10/29/2013
K090064 EMINENT SPINE EMINENT SPINE INTERBODY FUSION SYSTEM 04/09/2009
K230219 Eminent Spine, LLC Eminent Spine 3D Lumbar Interbody Fusion Systems 05/16/2023
K223671 Enztec Limited CONDUIT LLIF Straight Inserters 01/05/2023
K232014 Enztec Limited CONDUITÖ ATP Inserters 09/01/2023
K212823 Enztec Limited DePuy CONDUIT LLIF Angled Inserters 11/01/2021
K220449 Enztec Limited DePuy CONDUIT LLIF SQUID Inserter 06/28/2022
K160663 EVOLUTION SPINE, LLC Lumbar Interbody Fusion System (ALIF, PLIF, LLIF, TPLIF) 11/16/2016
K123607 EXACTECH, INC. OCTANE ELEVATE SPINAL IMPLANT SYSTEM 04/25/2014
K130434 EXACTECH, INC. OCTANE STRAIGHT, OCTANE STRAIGHT - LORDOTIC, OCTANE STRAIGHT I/R, OCTANE STRAIGHT I/R - LORDOTIC 05/01/2013
K150152 EXACTECH, INC. The Octane Straight Intervertebral Fusion Device, Ti Coated 05/11/2015
K203802 Expanding Innovations, Inc X-Pac Expandable Lumbar Cage System 06/07/2021
K220655 Expanding Innovations, Inc X-Pac Expandable Lumbar Cage System 03/24/2022
K222797 Expanding Innovations, inc X-Pac Expandable Lumbar Cage System 10/14/2022
K223174 Expanding Innovations, Inc. X-Pac Expandable LLIF Cage System 02/14/2023
K201145 Expanding Innovations, Inc. X-Pac Expandable Lumbar Cage System 09/10/2020
K133813 EXPANDING ORTHOPEDICS, INC. FLXFIT INTERVERTEBRAL BODY FUSION DEVICE 07/15/2014
K171519 Expanding Orthopedics, Inc. FLXfitÖ 09/15/2017
K162693 FACETLINK DBA LINKSPINE VertebraLINK Fusion Platform 03/29/2017
K180347 Fims Co., Ltd. 3d Cage 10/28/2019
K193255 FloSpine, LLC Largo PEEK Interbody System 02/20/2020
K192026 GBS Commonwealth Co., Ltd. Peridot Intervertebral body fusion System 11/26/2019
K182987 Genesys Spine Genesys Spine 3DP Lumbar Interbody System 12/12/2019
K220096 Genesys Spine Genesys Spine 3DP Lumbar Interbody System 03/09/2022
K171656 Genesys Spine Genesys Spine Apache Interbody Fusion System 07/13/2017
K153123 GENESYS SPINE Genesys Spine Apache Interbody Fusion System 04/26/2016
K130913 GENESYS SPINE GENESYS SPINE APACHE LATERAL LUMBAR INTERBODY FUSION SYSTEM 12/13/2013
K161438 GENESYS SPINE Genesys Spine Apache« Anterior Lumbar Interbody Fusion System 11/08/2016
K161404 Genesys Spine Genesys Spine Apache« Lateral Lumbar Interbody Fusion System 07/21/2016
K103034 GENESYS SPINE GENESYS SPINE INTERBODY FUSION SYSTEM 12/10/2010
K140411 GLOBUS MEDICAL INC. ALTERA SPACER 07/01/2014
K102293 GLOBUS MEDICAL INC. CALIBER SPACER 01/05/2011
K123231 GLOBUS MEDICAL INC. CALIBER SPACERS 01/18/2013
K171848 Globus Medical Inc. FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO Corpectomy Spacers, SUSTAIN Spacers, COALITION Spacers, PATRIOT Lumbar Spacers, PATRIOT Cervical Spacers, ALTERA Spacers, RISE Spacers, CALIBER Spacers, ELSA Spacers, LATIS 12/21/2017
K191391 Globus Medical Inc. HEDRON Lumbar Spacers 09/18/2019
K203278 Globus Medical Inc. INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental Plate-Spacer, ELSA Spacers 02/02/2021
K123913 GLOBUS MEDICAL INC. LATIS SPACER 05/13/2013
K221894 Globus Medical Inc. Lumbar Expandable lnterbody Spacers -Additional Indications/Implants 08/03/2023
K181357 Globus Medical Inc. PATRIOT« Lumbar Spacers, SUSTAIN« Spacers 12/06/2018
K192115 Globus Medical Inc. SABLE Expandable Spacer 01/14/2020
K151665 GLOBUS MEDICAL INC. SUSTAIN Additional Implants 03/16/2016
K143578 GLOBUS MEDICAL INC. SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers, INDEPENDENCE TPS Spacer, FORTIFY -R TPS Corpectomy Spacer, FORTIFY I-R TPS Corpectomy Spacer, XPand -R TPS Corpectomy Spacer, NIKO TPS Corpectomy Spacer 04/13/2016
K152022 GLOBUS MEDICAL INC. SUSTAIN« R Spacers, PATRIOT« Spacers, CALIBER« Spacers, RISE« Spacers, COALITION« Spacers, COALITION AGXÖ Spacers, INDEPENDENCE« Spacers, FORTIFY«-R Corpectomy Spacers, FORTIFY« I-R Corpectomy Spacers, XPand«-R Corpectomy Spacers, NIKO« Corpectomy Spacers 02/22/2017
K122097 GLOBUS MEDICAL, INC. PATRIOT SPACERS 12/06/2012
K072970 GLOBUS MEDICAL, INC. PATRIOT SPACERS 01/18/2008
K093242 GLOBUS MEDICAL, INC. PATRIOT TRANSCONTINENTAL LLIF SPACER 12/23/2009
K102313 GLOBUS MEDICAL, INC. PATRIOT TRANSCONTINENTAL M SPACERS 12/03/2010
K113447 GLOBUS MEDICAL, INC. RISE SPACER 01/26/2012
K130478 GLOBUS MEDICAL, INC. SUSTAIN AND SUSTAIN RADIOLUCENT SPACERS 07/26/2013
K221687 GS Medical Co. Ltd. Pegasus-X Expandable PLIF System 07/27/2022
K223868 GS Medical Co. Ltd. PYXIS 3D Titanium Cage System 04/26/2023
K131612 GS MEDICAL CO., LTD. ANYPLUS; ALIF PEEK CAGES, PLIF PEEK CAGES, T-PLIF PEEK CAGES, TLIF PEEK CAGES 04/18/2014
K111354 GS MEDICAL CO., LTD. GS MEDICAL ANYPLUS PEEK LUMBAR CAGES (ALIF AND DLIF) 10/17/2011
K170676 HD LifeSciences LLC HD Lumbar Interbody System 07/13/2017
K170511 HT Medical, LLC NeoFuse HA Enhanced PLIF/TLIF 04/25/2017
K153615 HT MEDICAL, LLC NeoFuse HA Enhanced PLIF/TLIF 05/06/2016
K173080 Huvexel Co., Ltd IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF) 10/31/2017
K100305 ICOTEC ETURN SPINAL IMPLANT MODEL ETURN XX-12; ETURN XX-16 WHERE XX=07, 09, 11, 13, OR 15 AND ETURN XX-12 K; ETURN XX-16 K WHER 07/21/2011
K141443 INFRONT MEDICAL, LLC INFRONT LUMBAR INTERBODY FUSION SYSTEM 08/28/2014
K133459 INNOVA SPINAL TECHNOLOGIES, LLC ELITE IBF 03/06/2014
K150954 INNOVA SPINAL TECHNOLOGIES, LLC Elite L Expandable Lumbar Fusion System 05/07/2015
K121581 INNOVASIS, INC. BOX PEEK VBR SYSTEM, 10/17/2012
K190684 Innovasis, Inc. LxHA PEEK Lateral IBF System 06/17/2019
K151785 INNOVASIS, INC. Px HA PEEK IBF System 10/14/2015
K150500 INNOVASIS, INC. Px PEEK IBF System 06/19/2015
K180078 Innovasis, Inc. Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System 04/17/2018
K183064 Innovasis, Inc. TxTi IBF System 06/28/2019
K201614 Innovasis, Inc. TxTiHA IBF System, AxTiHA Stand-Alone ALIF System 07/15/2020
K181397 Innovasive, Inc. DualX 09/27/2018
K072120 INNOVATIVE SPINAL TECHNOLOGIES INC PARAMOUNT INTERVERTEBRAL BODY FUSION DEVICE 10/11/2007
K093669 INNVOTEC SURGICAL, INC. SEC IBF CAGE 03/18/2010
K130506 INSTITUTE OF MUSCULOSKELETAL SCIENCE & EDUCATION IMSE P-TLIF 05/13/2013
K112986 INTEGRA SPINE (INTEGRA LIFESCIENCES) LATERAL FUSION DEVICE 05/01/2012
K182114 Integrity Implants Inc FlareHawk Interbody Fusion System 01/07/2019
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K210439 NuVasive, Incorporated NuVasive MOD-EX XLIF Interbody System 05/12/2021
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K192760 NuVasive, Incorporated NuVasive Modulus XLIF Interbody System 10/18/2019
K201692 NuVasive, Incorporated NuVasive Modulus XLIF Interbody System 10/29/2020
K203201 NuVasive, Incorporated NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL Interfixated System, Brigade Hyperlordotic System, Brigade Standalone System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fu 01/12/2021
K201820 NuVasive, Incorporated NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL Interfixated System, Brigade Standalone System and Brigade Hyperlordotic System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody 09/25/2020
K203714 NuVasive, Incorporated NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System, NuVasive CoRoent XL Interfixated System, Brigade System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, NuVasive C 12/23/2021
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K200953 NuVasive, Incorporated NuVasive« Cohere« Thoracolumbar Interbody System 10/06/2020
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K153782 NUVASIVE, INCORPORATED NuVasive« Lumbar Interbody Implants 03/24/2016
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K172341 NuVasive, Incorporated NuVasive« Modulus TLIF Interbody System 10/26/2017
K172123 NuVasive, Incorporated NuVasive« Modulus XLIF Interbody System 10/11/2017
K173892 NuVasive, Incorporated NuVasive« XLX Interbody System 05/04/2018
K143595 NuVasive, Incorporated NuVasive(R) CCX-L Interbody System 04/29/2015
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K221172 OC Medical Devices FOCUS Interbody System 10/14/2022
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