Product Code: MAX FDA class 2 21 CFR 888.3080

Intervertebral Fusion Device With Bone Graft, Lumbar

Orthopedic

The lumbar intervertebral fusion device with bone graft is an orthopedic implant intended to stabilize spinal segments and promote bony fusion, thereby restricting motion and decreasing pain in patients with lumbar spinal disorders. It is classified as FDA Class II under 21 CFR 888.3080 within the Orthopedic specialty, requiring 510(k) premarket clearance. The product code is MAX and the device carries an implant flag reflecting its surgical placement between vertebral bodies. Full GMP compliance is required.

510(k)s
870
FEI Numbers
422
Registration Numbers
422
Unique Applicants
396
Years Active
18

Basic Information

Product Code
MAX
Device Class
FDA class 2
Regulation Number
888.3080
Medical Specialty
Orthopedic
Review Panel
OR
Submission Type
1

Device Characteristics

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

Definition

Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.

510(k) Clearance History

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Related 510(k) Clearances

This FDA classification is associated with 870 510(k) clearances via K numbers.

K Number Device Name
K251741 PathLoc Lumbar Interbody Fusion Cage System
K251502 TruLift® Lateral Expandable Spacer & Lateral Buttress Plate System
K250827 aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion device; aprevo® anterior lumbar interbody fusion device with interfixation; aprevo® transforaminal lumbar interbody fusion device; aprevo® TLIF-CA Articulating System; aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X No Cams
K250987 aprevo® posterior/transforaminal lumbar interbody fusion device
K243816 Testa TP Pivoting Spacer System
K251003 X-PAC® LLIF Expandable Lateral Cage System
K251617 X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage System
K243973 FIX-L PEEK PLIF and T-PLIF System
K251335 Tera Lumbar Interbody Fusion System (Various PNs)
K243116 FlareHawk Interbody Fusion System
K250669 Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology
K250373 ProLift Expandable Spacer System
K250667 DeGen Medical Patient Specific Implant (PSI) System
K243074 Spectrum Spine Lumbar Cage System
K250186 GoLIF! Lumbar Interbody Fusion System
K242771 Tesera-k PL System and Tesera-k XL System
K241783 FortiVy™ OsteoVy™ Lumbar IBF
K241375 IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi Cervical Porous Ti Interbody System; IdentiTi NanoTec Cervical Interbody System; IdentiTi Cervical Standalone Interbody System; IdentiTi NanoTec Cervical Standalone Interbody System; IdentiTi ALIF Standalone Interbody System; IdentiTi NanoTec ALIF Standalone Interbody System; Transcend PEEK Interbody System; Transcend NanoTec Interbody System; Transcend Cervical PEEK Interbody System; Transcend NanoTec Cer
K243739 AxCess® Expandable Interbody System
K243668 ProLift Pivot Expandable Spacer System
K243670 Idys® LIF
K241073 DZ-Tabone Intervertebral Body Fusion Device
K242829 BluEX Lumbar Expandable Cage System
K242589 Scarlet® AL-T
K233947 KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage System
K242826 ProLift Wedge Expandable Spacer System
K242267 Gemini Medical Cage System
K242457 EARP Interbody System
K242364 IdentiTi™ II Interbody System
K240889 ARTFX Lumbar PEEK Cages
K233807 LumiVy™ Lumbar IBF System
K242147 Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody System
K241332 aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar interbody fusion devices with interfixation; aprevo® transforaminal lumbar interbody fusion device
K242509 HAnano InterFuse(R) Modular Interbody
K240250 3D Printed PEEK Interbody System
K241438 Signus Tetris™ St; Signus Tetris™ R St
K241164 IB3D™ PL Spinal System
K234035 COSINE™ Spacer
K232996 Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)
K241605 Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System with Nanotechnology
K241328 aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo® Transforaminal Lumbar Interbody Fusion device (TLIF); aprevo® Anterior Lumbar Interbody Fusion device with Interfixation (ALIF-X)
K240326 Solar™ Lumbar Interbody Fusion System
K241413 sagAlign Lumbar Cage System (Various PNs)
K234077 SPIRA® Anterior Lumbar Spacers
K241019 aprevo® TLIF-C Articulating System
K241466 Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System; Reef L Interbody System; Reef TO/TA System; Meridian Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; WaveForm A Interbody System
K240830 Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; FORZA XP Expandable Spacer System; Shoreline ACS Interbody System; Shoreline RT Interbody System; Meridian Interbody System; WaveForm A Interbody System
K240749 PILLAR SA Ti Spacer System (82-XXX)
K240566 Reef L Interbody System; WaveForm L Interbody System
K233509 Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation ALIF System
K232792 icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec ETurn™ TLIF Lumbar Cage)
K234150 Lucent® XP
K232282 aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal lumbar interbody fusion device
K233375 Tranquil-L Interbody System
K233075 “BioGend” Interbody Fusion System 001 Cage
K234087 restor3d TIDAL Lumbar Interbody Fusion System
K233744 Curiteva Porous PEEK Lumbar Interbody Fusion System
K233694 Meridian Interbody System; WaveForm A Interbody System
K230872 Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction Changeable Lumbar Cage System, KEYSTONE Cage System
K231743 F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro Lateral Plate System
K232611 TruLift Micro Expandable Spacer System & TruLift Expandable Spacer System
K232069 Expandable Lumbar Fusion Cage (Type I,Type II)
K232292 Peridot-EX Expandable Intervertebral Body Fusion System
K232504 Calibrate CCX Interbody System
K232014 CONDUIT™ ATP Inserters
K231680 AccelFix Lumbar Expandable Cage System
K221894 Lumbar Expandable lnterbody Spacers -Additional Indications/Implants
K231275 Exceed™ Biplanar Expandable Interbody System
K231438 Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody System
K231241 NanoHive Medical Lumbar Interbody System
K230942 SPIRA® Posterior Lumbar Spacers
K231252 Ventana™ L Spinal System
K231199 Solar Lumbar Interbody Fusion System
K231359 RODIN™ Expandable Lumbar Cage System
K230851 Kodiak Lumbar Spacer System
K231140 aprevo® transforaminal lumbar interbody fusion device
K230219 Eminent Spine 3D Lumbar Interbody Fusion Systems
K223335 SIRION Lateral Lumbar Interbody System
K223430 ProLift Micro Expandable Spacer System
K223868 PYXIS 3D Titanium Cage System
K223611 Calibrate LTX Interbody System
K223418 DeGen Impulse AM™ System
K223688 CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ Instruments
K223776 PEEK Spinal Infusion Cage
K223174 X-Pac Expandable LLIF Cage System
K223474 PathLoc-TA Expandable Lumbar Cage System
K223412 LumiVy™ Lumbar IBF System
K223671 CONDUIT LLIF Straight Inserters
K223654 Medussa-PL Cage
K213653 4CIS BLACK MARLIN PLIF CAGE SYSTEM, 4CIS DOLPHIN TLIF CAGE SYSTEM
K223251 Hexanium PLIF
K223153 Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface Technology
K221182 Southern Transforaminal Lumbar Interbody Fusion (TLIF)
K221806 TruLift Lateral Expandable Spacer System & Lateral Plate System
K222455 Calibrate LTX Interbody System
K222732 WaveForm A Interbody System
K221719 ABTross ALIF Expandable Cage System
K223065 Adcura® Sagittae® Lateral Lumbar Interbody Fusion Devices
K222203 DualXSLIM(R) T/PLIF
K222797 X-Pac Expandable Lumbar Cage System
K221858 ZSFab Lumbar Interbody System
K221172 FOCUS Interbody System
K222028 IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™ PEEK Interbody System, Transcend™ NanoTec™ Interbody System, IdentiTi™ ALIF Standalone Interbody System, IdentiTi™ NanoTec™ ALIF Standalone Interbody System
K213417 Ghost Spacer System
K213641 MONDRIAN ALIF Cage with Supplementary Fixation Plate
K220953 ChoiceSpine TigerShark™ M, Modular Interbody System
K221325 CONDUIT Lateral Switch Plate
K221844 TDM Lumbar Interbody Fusion Cage System
K222082 aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal lumbar interbody fusion devices
K221687 Pegasus-X Expandable PLIF System
K221535 Align Lumbar Interbody Fusion System
K220449 DePuy CONDUIT LLIF SQUID Inserter
K220478 NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody System
K220523 restor3d TiDAL Lumbar Interbody Fusion Device
K220782 IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™ PEEK Interbody System, Transcend™ NanoTec™ Interbody System, IdentiTi™ ALIF Standalone Interbody System, IdentiTi™ NanoTec™ ALIF Standalone Interbody System, IdentiTi™ Cervical Standalone Interbody System, IdentiTi™ NanoTec™ Cervical Standalone Interbody System
K220581 Zavation eZspand Interbody System
K220902 Navagio Lumbar Cage
K220711 SeaSpine Meridian System, SeaSpine Meridian Anterior Plate System
K213420 WaveForm L System, WaveForm TO System, WaveForm TA System
K212477 EARP Interbody System
K214010 Anteralign Spinal System with Titan nanoLOCK Surface Technology
K212811 Ti3Z Lumbar Interbody System
K213355 Toro-L Interbody Fusion System
K220655 X-Pac Expandable Lumbar Cage System
K220453 FlareHawk Interbody Fusion System
K220096 Genesys Spine 3DP Lumbar Interbody System
K213441 PathLoc Lumbar Interbody Fusion Cage System
K212930 LumiVy Lumbar IBF System
K213951 FORZA XP Expandable Spacer System
K203714 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 Cohere Thoracolumbar Interbody System, NuVasive Modulus XLIF Interbody System, NuVasive Modulus TLIF Interbody System, NuVasive Modulus ALIF System, NuVasive Attrax Putty
K212524 Anteralign Spinal System with Titan nanoLOCK Surface Technology
K212075 ShurFit Lumbar Interbody System
K212050 NGM WAVE PLIF Cage
K212653 Catalyft LS Expandable Interbody System
K211845 Deploy Expandable Interbody System
K212823 DePuy CONDUIT LLIF Angled Inserters
K212831 MectaLIF Extension
K212389 Advantage Lumbar System - ALIF, PLIF, DLIF, TLIF
K212520 ProLift Micro Expandable Spacer System
K211740 DualX
K211805 IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec Interbody System, Transcend NanoTec Interbody System
K211689 KEYSTONE PEEK Cage System
K211474 Kleiner KG2 System
K212540 Explorer TO System
K203014 EndoLIF Delta-Cage and DoubleWedge-Cage
K212070 KMTI S141 Lumbar Interbody Fusion System
K210090 Impulse AM Interbody Fusion System
K211413 BEE PLIF Cage
K210800 IO Expandable Lumbar Interbody Fusion System
K211873 PSX Interbody System
K211388 Lateral Spine Truss System (LSTS) Interbody Fusion Device
K210497 SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu a•POD-L NanoMetalene, SeaSpine Vu e•POD System, SeaSpine Vu a•POD Prime NanoMetalene Intervertebral, SeaSpine Shoreline ACS - Anterior Cervical Standalone, SeaSpine Cervical Interbody RT System, SeaSpine Cambria System, SeaSpine Regatta Lateral System, SeaSpine Reef TO/TA System, SeaSpine Reef TH System, SeaSpine Meridian System
K203003 Pantheon IBFD
K210542 aprevo Transforaminal IBF
K210044 Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System, Ceres-C Spinal System, Omega XP Spinal System
K211306 LABYRINTH
K210595 SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar Spacers
K203802 X-Pac Expandable Lumbar Cage System
K210583 SeaSpine WaveForm™ A Interbody System
K211258 Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA Interbody System, Endoskeleton TAS & TAS Hyp Interbody System, Endoskeleton TL Interbody System, Endoskeleton TL Hyp. Interbody System, Endoskeleton TO Interbody System, Endoskeleton TT Interbody System
K210425 Catalyft PL Expandable Interbody System
K210214 NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody System
K210439 NuVasive MOD-EX XLIF Interbody System
K210728 CONDUIT Instruments
K210061 ProLift Lateral HELO Fixated
K201024 Expandable Titanium PLIF/TLIF System
K200919 Idys ALIF 3DTi
K203254 Lucent 3D Spinal System
K203038 Toro-L Interbody Fusion System
K203361 ProLift Wedge Expandable Spacer System
K210359 Hexanium TLIF
K203576 FORZA Ti Spacer System
K210155 Duo Expandable Interbody Fusion System
K202380 Born PT-LIF Cage HA
K200551 MectaLIF Transforaminal TiPEEK
K203278 INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental Plate-Spacer, ELSA Spacers
K203531 XYPAN Expandable Lumbar Cage System
K203327 VERTACONNECT TLIF Cage
K203683 CarboClear Lumbar Cage System
K203308 Ali Interbody Fusion System
K203201 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 Fusion System, Cohere Thoracolumbar Interbody System, Modulus XLIF Interbody System, Modulus TLIF Interbody System, Modulus ALIF System
K202495 SIRION Lateral Lumbar Interbody Fusion
K202820 Australis Anterior Lumbar Cage System
K202298 Lucent XP, Lucent XP Curved
K201287 Impulse Interbody Fusion System
K201755 WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody System
K202034 aprevo Intervertebral Body Fusion Device
K201193 SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu a•POD-L NanoMetalene; SeaSpine Vu e•POD System; and SeaSpine Reef TH System, SeaSpine Vu a•POD Prime NanoMetalene IBD; and SeaSpine Shoreline ACS, SeaSpine Cambria System; SeaSpine Regatta Lateral System; and SeaSpine Meridian System, Shoreline Cervical Interbody RT System; and SeaSpine Beachside System
K202587 ATEC Lateral Interbody System
K202198 FlareHawk Interbody Fusion System
K200316 UNiD IB3D ALIF
K201692 NuVasive Modulus XLIF Interbody System
K200084 Zavation IBF System
K202305 Zavation IBF System
K201939 GAIA Lumbar Interbody Fusion Device (LIFD) Family
K201453 Fortilink Cages with TiPlus Technology
K200953 NuVasive® Cohere® Thoracolumbar Interbody System
K201820 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 Fusion System, Cohere Thoracolumbar Interbody System, Modulus XLIF Interbody System, Modulus TLIF Interbody System, 3DP Interfixated ALIF System
K201367 FlareHawk TiHawk9 Interbody Fusion System
K201145 X-Pac Expandable Lumbar Cage System
K201721 TruLift Expandable Spacer System
K200958 MODULIF-A Anterior Lumbar Interbody Fusion System
K201267 Adaptix Interbody System with Titan nanoLOCK Surface Technology
K192863 MONDRIAN Lumbar Interbody Fusion Cage System
K201500 Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar Spacer
K201614 TxTiHA IBF System, AxTiHA Stand-Alone ALIF System
K201605 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
K193172 Luna XD Ti Interbody Fusion System
K193106 SpineFrontier Lumbar Interbody Fusion Device System
K200283 Medussa-PL Cage
K200879 SeaSpine Meridian System, SeaSpine Regatta Lateral System
K200920 Idys ALIF ZP 3DTi
K200969 NEXXT MATRIXX System
K191906 MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed PLIF, HYPERION 3D Printed TLIF, CALYPSO 3D Printed LLIF, and ANTARES 3D Printed ALIF
K200991 EVOL Spinal Interbody System
K193457 AUDERE Lumbar Spacer System
K200816 SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices
K193636 SeaSpine Reef TH System
K200613 Tritanium® X TL Expandable Curved Posterior Lumbar Cage
K191353 COMET Lumbar Interbody Fusion Cage
K200552 EVOS Lumbar Interbody System
K192006 SIRION Lateral Lumbar Interbody System
K193541 NuVasive Cohere Thoracolumbar Interbody System
K191788 CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium, DIVERGENCE-L Anterior/Oblique Lumbar Fusion System
K193418 SeaSpine Skipjack System
K200048 MectaLIF Anterior Simple
K193378 CarboClear Lumbar Cage System
K190363 Omnia Medical TiBrid Cervical Cage, Omnia Medical TiBrid Lateral Cage, Omnia Medical TiBrid ALIF Cage, Omnia Medical TiBrid PLIF Cage, Omnia Medical TiBrid TLIF Cage
K193255 Largo PEEK Interbody System
K193203 MOJAVE Expandable Interbody System
K193521 Steerable Plateau Ti
K193258 ProLift Expandable System
K192502 Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System, Capstone™ Spinal System, Capstone PTC™ Spinal System, Capstone Control™ Spinal System, Capstone Control PTC™ Spinal System, Clydesdale™ Spinal System, Clydesdale PTC™ Spinal System, Cornerstone™ PSR Cervical Fusion System, Crescent™ Spinal System, Crescent™ Spinal System Titanium, Divergence™ Anterior Cervical Fusion System (For Stand-Alone Interbody Device Only), Divergence-L™ Anterior/Oblique Lumbar Fus
K193370 Nexxt Matrixx System
K192115 SABLE Expandable Spacer
K193645 nva, nvp, and nvt
K192687 TrellOss™-L MPF
K192497 EVOL ha - D Lateral Interbody Fusion System
K192718 Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology
K193174 Keos Lumbar IBFD
K181548 Pantheon Spinal Pontus Interbody Fusion Device
K191796 Neo Cage System
K182987 Genesys Spine 3DP Lumbar Interbody System
K192132 SeaSpine Beachside System
K192026 Peridot Intervertebral body fusion System
K192248 Cortina™ [MAX] Lumbar Cage System
K190721 LongBow Ti
K190544 XIHPOS™ ZFUZE™ Interbody Fusion System
K191134 IB3D ALIF
K180347 3d Cage
K192760 NuVasive Modulus XLIF Interbody System
K192434 DualX Lumbar Intervertebral Body Fusion Device
K191791 TranS1 Interbody Fusion System
K190483 SPIRA Open Matrix ALIF and LLIF
K191391 HEDRON Lumbar Spacers
K190563 4CIS PEEK PLIF Cage, 4CIS Pebble Beach PEEK PLIF Cage, 4CIS Torrey Pines PEEK TLIF Cage, 4CIS Dunes PEEK DLIF Cage, 4CIS Augusta PEEK ALIF Cage
K190708 AccelFix Lumbar Interbody Fusion Cage System
K191516 Ali Interbody Fusion System
K190398 Republic Spine Restore Intervertebral Body Fusion System
K183407 Triton Cage
K191339 Zavation eZspand Interbody System
K191311 ATEC Lateral Interbody System
K183249 Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar Cage
K190488 ProLift Expandable System
K190680 FAVO S-TLIF
K182158 UNiD Patient-matched PLIF cage
K191408 Nexxt Matrixx System
K183243 Velofix TLIF Cage
K191367 Harrier-SA Lumbar Interbody System
K190498 Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs: Fortilink®-TS IBF System, Fortilink®-L I BF System, Fortilink®-C IBF System
K190959 ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with TiONIC Technology
K183064 TxTi IBF System
K190684 LxHA PEEK Lateral IBF System
K191005 ProLift® Expandable System
K183560 Luna 3D GEN2 Interbody Fusion System
K190092 UNiD Patient specific 3D printed TLIF cage
K190165 Capstone Control™ Spinal System
K182877 HALF DOME Posterior Lumbar Interbody System
K190364 CancelleX Porous Titanium Lumbar Interbody Device
K183184 FlareHawk Interbody Fusion System
K182349 CONCORDE LIFT
K182920 MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar Interbody Fusion (PLIF); HYPERION™ PEEK Transforaminal Lumbar Interbody Fusion (TLIF); CALPYSO™ PEEK Lateral Lumbar Interbody Fusion (LLIF); ANTARES™ PEEK Anterior Lumbar Interbody Fusion (ALIF)
K183092 Kuros TLIF Cage
K190055 Duo Lumbar Interbody Fusion Device
K173518 Spectrum Spine Expandable Cages (SSEC)
K190193 SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices
K183705 IdentiTi Porous Ti Interbody System
K183259 Idys™ TLIF TiVac
K182406 Altus Spine Interbody Fusion System
K183049 Reliance Lumbar IBF System
K183659 Omnia Medical Rotary PLIF System
K183447 EIT Cellular Titanium Lumbar Cage - T/PLIF
K181048 Neo Cage System TM
K180822 VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion System
K180230 NEST Interbody System
K180228 II-Type Intervertebral Spacer
K182210 TiWAVE-L Porous Titanium Lumbar Cage
K182114 FlareHawk Interbody Fusion System
K181589 Curiteva Lumbar Interbody Fusion System
K183239 CoreLink F3D™ Lateral System
K181899 ROCCIA® PLIF
K181625 Life Spine Resolute™ Threaded Cage System
K182584 Lucent® XP
K181357 PATRIOT® Lumbar Spacers, SUSTAIN® Spacers
K181231 DePuy Synthes T-PAL Spacer System
K181970 MectaLIF Posterior Extension
K182746 ATEC ALIF and LLIF Spacer System
K182470 Plateau Spacer System
K181963 ostaPek Interbody Fusion Cages
K181829 Velofix TLIF Cage
K181837 Spinal Elements Ti-Bond coated devices
K182322 Duo Lumbar Interbody Fusion Device
K181644 EIT Cellular Titanium® Lumbar Cage LLIF
K181860 NuVasive Cohere Thoracolumbar Interbody System
K181531 SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices
K181397 DualX
K181591 Fixated Asfora BULLET CAGE® (FABC)
K181702 Tranquil-L Interbody System
K181337 Sypher Spacer System
K181655 Renovis S180 Lateral Lumbar Interbody Fusion System
K181380 LnK Lumbar Interbody Fusion Cage System
K181483 Tranquil Interbody System
K180373 CancelleX Porous Titanium Lumbar Interbody Device
K181347 Aries® Lumbar Interbodies
K181792 Duo™ Lumbar Interbody Fusion Device
K180990 TirboLOX-L Lumbar IBFD
K180777 K2M Expandable Interbody System
K180556 Corelink Foundation 3D Anterior Lumbar System
K180076 Ti 3Z Interbody System
K181453 ATEC ALIF Spacer System
K173947 Lumbar Interbody Fusion System (OLLIF)
K181079 SeaSpine Regatta Lateral System
K181014 Tritanium PL Cage
K181030 Rubicon Lumbar Interbody Fusion System
K180963 ROCCIA ALIF, ROCCIA TLIF
K181246 Zavation IBF System
K173864 Peekplus® Interbody Fusion Device
K181203 Juliet Ti
K180724 SPIRA Open Matrix LLIF
K173189 Lumfuse TP
K180687 Reliance Lumber IBF System
K173347 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
K180891 EVOL Spinal Interbody System, EVOS Lumbar Interbody System
K180437 Hexanium® TLIF
K173892 NuVasive® XLX Interbody System
K180071 STYLO Interbody Fusion Device
K171151 ACRON™ TLIF System
K173782 UNiD Patient Specific 3D printed cage
K172947 HALF DOME Posterior Lumbar Interbody System
K180078 Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System
K180431 Cortina [MAX] Lumbar Cage System
K171495 Zyston Strut Open Titanium Spacer System
K173537 CONCORDE LIFT™
K173025 NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP Expandable XLIF System
K172105 The Plateau-LO Spacer System
K172828 Double Medical Cage System
K172816 TiGer Shark™ System
K171312 FortiCore®
K173283 Reliance Lumbar IBF System
K172696 FORZA® XP Expandable Spacer System
K173476 Tritanium® TL Curved Posterior Lumbar Cage
K173702 Juliet Ti LL
K171848 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 Spacers, MONUMENT Spacers, InterContinental Plate-Spacer, MAGNIFY Spacers, INDEPENDENCE Spacers
K171434 ROCCIA® MultiLIF
K173182 ProLift® Expandable System
K172888 EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular Titanium® TLIF Cages, EIT Cellular Titanium® ALIF Cages
K172465 Idys™ TLIF 3DTi Cages
K172349 InFill® Interbody Fusion Device
K172009 Cascadia Interbody System
K170389 TAURUS PEEK Cage System
K172756 Varian cage
K173153 Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion System
K173260 SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica; SeaSpine Spacer System -Hollywood, Hollywood VI, Ventura, Pacifica; SeaSpine Vu e·POD System
K172419 Velofix™ TLIF Cage
K170553 Altus Spine Interbody Fusion System
K172020 Arlington PLIF/TLIF Cage
K170235 Lucent®
K163595 IMPIX 3D Print Cages
K172392 Lateral Spinal Truss System (LSTS) Interbody Fusion Device
K170341 Medussa-PL Cage
K173080 IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF)
K173022 SeaSpine Ventura NanoMetalene System
K172341 NuVasive® Modulus TLIF Interbody System
K172334 Ortus™ Expandable Lumbar Interbody Fusion System
K171914 Cortina™ Lumbar Cage System
K172343 Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D Technology
K172123 NuVasive® Modulus XLIF Interbody System
K171689 ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with TiONIC Technology
K170119 Calix Lumbar Spinal Implant System
K171633 NuVasive TLX Interbody System
K171107 CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal System
K172199 ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium
K172064 Ti-Diagon Oblique TLIF
K171519 FLXfit™
K171893 Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone Synergy Cervical Interbody Fusion System (Slate)
K171351 Posterior Spine Truss System (PSTS) Interbody Fusion Device
K171329 Altus Spine Titanium Interbody Fusion System
K171660 Duo Lumbar Interbody Fusion Device
K171657 ShurFit 2C Lumbar Interbody Fusion System
K170888 Renovis S141 Lumbar Interbody Fusion System
K170851 Anterior Spine Truss System (STS) Interbody Fusion Device
K170919 The TiBow Expandable Spacer System
K171630 LumFuse-TP
K171724 Rampart L Lumbar Interbody Fusion Device
K171425 CONCORDE LIFT
K171656 Genesys Spine Apache Interbody Fusion System
K170676 HD Lumbar Interbody System
K170503 EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular Titanium TLIF Cages, and EIT Cellular Titanium ALIF Cages
K171031 CRESCENT™ Spinal System
K170399 Endoskeleton TO Interbody Fusion Device (IBD)
K161710 SAGICO IBF SYSTEM – ARIA LUMBAR, SAGICO IBF SYSTEM – ARION CERVICAL
K170297 Tranquil Interbody System
K170962 NuVasive® CoRoent® Thoracolumbar System
K163506 Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar Interbody Fusion System
K171468 FUSE Spinal System
K162986 SPIRA Open Matrix ALIF
K170890 TELIX K Interbody System
K170395 Talos® Lumbar (HA) PEEK IBF Devices
K162212 DIVERGENCE-L ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM
K171097 MOJAVE Expandable Interbody System
K163481 HALF DOME Posterior Lumbar Interbody System
K163707 NuVasive CoRoent Ti-C System
K170572 Summit Spine Yellowstone Lumbar Interbody Fusion System
K170511 NeoFuse HA Enhanced PLIF/TLIF
K170643 Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) System
K163386 Keos Lumbar IBFD
K163246 Leva Anterior Expandable Spacer System
K162206 Zavation IBF
K170243 LOSPA IS TLIF & DLIF Cages
K162693 VertebraLINK Fusion Platform
K163230 NuVasive Modulus XLIF Interbody System
K163364 MOJAVE Expandable Interbody System
K170512 Altus Spine Titanium Interbody Fusion System
K163409 Rampart(TM) T Lumbar Interbody Fusion Device
K152022 SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION® Spacers, COALITION AGX™ Spacers, INDEPENDENCE® Spacers, FORTIFY®-R Corpectomy Spacers, FORTIFY® I-R Corpectomy Spacers, XPand®-R Corpectomy Spacers, NIKO® Corpectomy Spacers, MONUMENT™ Spacers, ALTERA™ Spacers, MAGNIFY™ Spacers, InterContinental® Plate-Spacer
K162918 Atlas Spine Expandable Interbody System
K162879 Elite Expandable Interbody Fusion Device
K160976 Altus Spine Interbody Fusion System
K163180 Hubble II
K162446 FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion System
K162327 COUGAR® LS Lateral Cage System and COUGAR® System
K162103 Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine Interbody Fusion System (Harrier™), Choice Spine Vertebral Body Replacement System (Hawkeye™)
K162431 Luna 3D Interbody Fusion System
K160959 Xsert Lumbar Expandable Interbody System
K160663 Lumbar Interbody Fusion System (ALIF, PLIF, LLIF, TPLIF)
K162262 Tritanium® PL Cage
K161438 Genesys Spine Apache® Anterior Lumbar Interbody Fusion System
K160924 Amendia Interbody Fusion Devices
K162358 T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System
K162715 SeaSpine Spacer System- Hollywood NanoMetalene, Hollywood VI NanoMetalene, Ventura NanoMetalene; SeaSpine Cambria NanoMetalene
K160074 Rampart D Lumbar Interbody Fusion Device
K160076 XCage™ Interbody Fusion System
K162426 nva, nvp, and nvt
K162264 Cascadia Interbody System
K153665 PROW FUSION-L
K161888 JULIET® LL Lateral Lumbar Cage
K161485 Nanovis Intervertebral Body Fusion System and Forticore(R)
K161230 NuVasive Lumbar Interbody Implants
K160646 XYcor® Expandable Spinal Spacer System
K161405 Valeo II Interbody Fusion Device System
K160856 SpineView X-Pac Expandable Lumbar Cage System
K160699 VIRTU Lumbar Spacer System
K161404 Genesys Spine Apache® Lateral Lumbar Interbody Fusion System
K160955 Tritanium® PL Cage
K160631 Keos Lumbar IBFD
K153621 Juliet® Ti
K160906 Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device, Rampart A lumbar Interbody Fusion Device
K153786 PROW FUSION-V
K153105 MLX™ - Medial Lateral Expandable Lumbar Interbody System
K160715 AccuLIF TL and PL Cage
K152501 Spinal Jaxx Interbody Fusion Device
K160916 CoRoent® Ti-C System
K160874 Nanovis Intervertebral Body Fusion System and FortiCore®
K152011 Lucent Intervertebral Body Fusion Device
K153436 LATERAL Spine Truss System
K160463 Reliance Lumbar IBF System
K153107 Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™ Lateral Access & Interbody Fusion System, Choice Spine Interbody Fusion System
K153615 NeoFuse HA Enhanced PLIF/TLIF
K153783 SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIF
K153123 Genesys Spine Apache Interbody Fusion System
K153222 Leva Spacer System
K153419 NuVasive CoRoent Thoracolumbar System
K143578 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
K160464 Opticage(R) Expandable Interbody Fusion Device
K153495 Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T Implant System
K152200 SurgTech Interbody System
K160547 Cascadia Interbody System
K153782 NuVasive® Lumbar Interbody Implants
K153627 NuVasive® TLX Interbody System
K151665 SUSTAIN Additional Implants
K160418 PERIMETER Interbody Fusion Device
K153400 ProLift Expandable System
K151406 Cogent Lateral Interbody System
K152539 SpineView X-Pac Expandable Lumbar Cage System
K153082 Rampart A Lumbar Interbody Fusion Device
K152512 Half Dome Posterior Lumbar Interbody System
K153695 Biomet Spine Fusion System
K151726 AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK Spacer, AVS Navigator PEEK Spacer, AVS ARIA PEEK Spacer
K152620 Spine Wave Gen II Expandable Interbody System
K153356 Spine Innovation Interbody System
K152475 FORZA PTC Spacer System
K151310 Amendia Interbody Fusion Devices
K152651 AccuLIF TL and PL Cage
K151900 VariLift-L Interbody Fusion Device
K152355 Twin Peaks Lumbar Interbody Fusion System
K151773 CONCORDE Bullet Lumbar Interbody System
K152304 Tritanium PL Cage
K152259 InFill Interbody Fusion Device
K152277 PIVOX(tm) Oblique Lateral Spinal System
K151819 Integrity Spine Lumbar Interbody Fusion System
K152156 Opticage Expandable Interbody Fusion Device
K151785 Px HA PEEK IBF System
K151352 CONCORDE Bullet Spinal System
K151408 LOSPA IS Spinal System
K143518 Valeo Spacer System and Valeo II Interbody Fusion Device System
K143479 Bluefin Interbody System
K151472 NuVasive CoRoent Lumbar System
K151322 Amendia Interbody Fusion Devices
K151756 STERISPINE LC CAGE
K150481 Cascadia Interbody System
K151140 LnK Lumbar Interbody Fusion Cage System
K151056 Aesculap T-Space PEEK and XP Spinal System
K150395 Omega LIF System
K151374 NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable XLIF System
K151128 CAPSTONE Spinal System, CLYDESDALE Spinal System
K151483 Biomet Spine Fusion System
K151020 Rampart-T Interbody Fusion System
K143143 PATHWAY ELIF
K151654 PROW FUSION
K151184 InFill Interbody Fusion Devices
K150321 EVOS Lumbar Interbody System
K151581 Leva Spacer System
K151143 EndoLIF On-Cage
K150500 Px PEEK IBF System
K151276 DePuy Synthes T-PAL Ti Spacer
K150135 DIVERGENCE-L Anterior/Oblique Lumbar Fusion System
K142559 ELEVATE Spinal System
K143740 Battalion Universal Spacer System
K150061 Lucent; Lucent Ti-Bond Systems
K142504 SpineFrontier Lumbar Interbody Fusion Device System
K150152 The Octane Straight Intervertebral Fusion Device, Ti Coated
K150954 Elite L Expandable Lumbar Fusion System
K143595 NuVasive(R) CCX-L Interbody System
K142392 Zavation Posterior LEIF
K140348 INTERBODY CAGE
K143258 PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)
K150206 InFill Interbody Fusion Devices
K143158 Xenco Medical Lumbar Interbody System
K141665 NuVasive CoRoent System
K142634 Biomet Spine Fusion System
K150285 Leva(TM) Spacer System
K143616 AccuLIF TL and PL Cage
K143297 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)
K143126 Renovis S141 Lumbar Interbody Cage System
K141980 LEVA (TM) SPACER SYSTEM
K142488 SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura) NanoMetalene, Cambria NanoMetalene , Vu aPOD-L NanoMetalene, Vu ePOD NanoMetalene
K141135 JULIET LL
K142594 nva, nvp, nvt
K140716 OPTICAGE EXPANDABLE INTERBODY FUSION DEVICE
K142023 LUNA INTERBODY SYSTEM
K141896 COROENT SYSTEM
K142347 Amedica Valeo II Interbody Fusion Device
K141953 ENDOSKELETON; TA IBD AND VBR, TO AND TT, TAS, TC, TL
K142101 ABACUS (TM) SPACER SYSTEM
K142589 Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS, Endoskeleton TAS, Endoskeleton TC, Endoskeleton TL
K142193 COGENT MED-LIF XL
K142277 JULIET PO
K140319 COROENT TI-C SYSTEM
K140577 INNESIS PEEK TL CAGE
K133577 CLYDESDALE(R) SPINAL SYSTEM
K142112 4WEB SPINAL IMPLANT PRODUCTS
K133717 LONGBOW SPACER SYSTEM
K141405 MOBIS II ST SPINAL IMPLANT
K141443 INFRONT LUMBAR INTERBODY FUSION SYSTEM
K140770 MLX - MEDIAL LATERAL EXPANDABLE LUMBAR INTERBODY SYSTEM
K132907 PLIF LITE AND TLIF LITE
K141217 ACCULIF TL AND PL CAGE
K140142 CHOICE SPINE LUMBAR SPACER SYSTEM (SABRE, SHARK, HORNET, HARPOON)
K133813 FLXFIT INTERVERTEBRAL BODY FUSION DEVICE
K133053 MILESTONE SPINAL SYSTEM
K140162 AP EXPANDABLE XLIF SYSTEM
K140055 ENDOSKELETON(R) TL INTERBODY FUSION DEVICE
K140411 ALTERA SPACER
K140659 COROENT THORACOLUMBAR IMPLANTS
K140759 BENGAL SYSTEM, BENGAL STACKABLE SYSTEM, CONCORDE BULLET LUMBAR, CONCORDE INLINE LUMBAR, COUGAR SYSTEM, COUGAR LS LATERAL
K140564 BN LUMBAR CAGE SYSTEM
K132852 PEEK CAGE FOR THE VERTEBRAL SPINE
K140709 SKYHAWK INTERBODY FUSION SYSTEM
K133514 XCAGE INTERBODY FUSION SYSTEM
K133418 INTEGRA EXPANDABLE INTERVEREBRAL BODY FUSION DEVICE (IBD) SYSTEM
K123607 OCTANE ELEVATE SPINAL IMPLANT SYSTEM
K140303 ALAMO T
K140474 JULIET OL
K131612 ANYPLUS; ALIF PEEK CAGES, PLIF PEEK CAGES, T-PLIF PEEK CAGES, TLIF PEEK CAGES
K132738 COGENT MED-LIF
K133340 SPINEWORKS ANTERIOR LUMBAR DEVICE
K140007 ABACUS TM SPACER SYSTEM
K133614 ALEUTIAN IBF SYSTEM
K133721 INFILL 41-TLIF CONVEX OBLIQUE DEVICE, INFILL 43-TLIF CONTOUR OBLIQUE, INFILL 44-TLIF CONTOUR OBLIQUE AND THE INFILL 60
K133455 CROSSFUSE II CORONAL TAPER, CROSSFUSE II HYPERLORDOTIC
K134038 CAMBER SPINE DIAGON OBLIQUE CAGE
K133893 STERISPINE LC CAGE
K133205 CAPSTONE PTC SPINAL SYSTEM, CLYDESDALE PTC SPINAL SYSTEM
K133459 ELITE IBF
K133583 OPTICAGE INTERBODY FUSION DEVICE, MODEL SERIES 9070
K133557 JULIET LL LATERAL LUMBAR CAGE
K131292 DEROYAL SPINE SPACER SYSTEM
K133967 INTERBODY CAGE SYSTEM
K133192 MECTALIF TIPEEK
K133184 ARDIS INTERBODY SYSTEM
K132421 AESCULAP PEEK XP SPINAL IMPLANT SYSTEM
K133371 RAMPART-L
K133645 PERIMETER C SPINAL SYSTEM, CAPSTONE SPINAL SYSTEM, CAPSTONE L SPINAL SYSTEM, PERIMETER SPINAL SYSTEM
K132601 COROENT STERILE IMPLANTS SYSTEM
K133650 CAPSTONE SPINAL SYSTEM
K132790 INFIX ANTERIOR LUMBAR SYSTEM
K130913 GENESYS SPINE APACHE LATERAL LUMBAR INTERBODY FUSION SYSTEM
K132897 CLYDESDALE SPINAL SYSTEM
K133126 K7 LUMBAR SPACERS
K133216 CRESCENT SPINAL SYSTEM
K131669 PERIMETER INTERBODY FUSION DEVICE
K130274 BIOLIGN ACIF SYSTEMS, BIOLIGN STACC ACIF SYSTEM, BIOLIGN TLIF SYSTEM
K131350 CALIX LUMBAR SPINAL IMPLANT SYSTEM
K130254 PROW FUSION
K131178 IDYS LIF CAGES
K131981 CEZANNE II INTERBODY FUSION SYSTEM
K132719 STAXX IBL SYSTEM
K132700 PERIMETER INTERBODY FUSION DEVICE
K132479 OPTICAGE INTERBODY FUSION DEVICE, MODEL 9080-00
K132053 RAMPART-O, RAMPART-T
K132505 ACCULIF TL AND PL CAGE
K131540 INTERFUSE L INTERVERTEBRAL BODY FUSION DEVICE
K131296 VARILIFT-L INTERBODY FUSION DEVICE
K131242 ARDIS INTERBODY SYSTEM
K131082 INTERFORM INTERBODY CAGE SYSTEM
K131071 STAXX IBL SYSTEM
K130820 EXPANDABLE LUMBAR INTERBODY SYSTEM
K130478 SUSTAIN AND SUSTAIN RADIOLUCENT SPACERS
K123027 CAPSTONE(R) SPINAL SYSTEM
K131077 LIFE SPINE PLATEAU SPACER SYSTEM
K131671 MECTALIF
K131372 MOBIS II
K122957 TEZO TITANIUM CAGE FAMILY
K131443 COALIGN INNOVATIONS ACCULIF XL IBF CAGE
K130630 PLATEAU SPACER SYSTEM TITANIUM
K124012 INFILL OBLIQUE TLIF DEVICE
K131216 RAMPART O
K130699 ALEUTIAN SPINAL SYSTEM
K122639 SYNTHES SYNCAGE EVOLUTION SPACER
K130506 IMSE P-TLIF
K123913 LATIS SPACER
K130434 OCTANE STRAIGHT, OCTANE STRAIGHT - LORDOTIC, OCTANE STRAIGHT I/R, OCTANE STRAIGHT I/R - LORDOTIC
K113781 PANTHEON SPINAL IBFD SYSTEM
K130548 EPICAGE INTERBODY FUSION DEVICE
K123461 STAXX(R) IB SYSTEM
K123978 CAPSTONE L SPINAL SYSTEM
K130194 ACCULIF XL CAGE
K123997 TRANS1LATERAL INTERBODY FUSION SYSTEM
K123100 INTESS LUMBAR CAGE
K130396 RAMPART O AND RAMPART P
K123652 SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DEVICE
K122037 ANATOMIC PEEK CERVICAL FUSION SYSTEM CORNERSTONE PSR CERVICAL FUSION SYSTEM PEEK PREVAIL CERVICAL INTERBODY DEVICE CAPST
K123602 TM ARDIS INTERBODY SYSTEM INSERTER
K122967 LUCENT
K123969 XIPHOS
K123281 ACCULIF TL-PEEK CAGE
K123231 CALIBER SPACERS
K120464 INNESIS PEEK CAGE
K123752 ACCULIF TL AND PL CAGE
K121254 CAMBER SPINE TECHNOLOGIES TLS 5.0 INERBODY CAGE
K123180 FALCON SPACER
K121693 A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE AIS)
K122097 PATRIOT SPACERS
K123207 PRIMALIF TM LLIF UNITARY PEEK LATERAL LUMBAR INTERBODY FUSION SYSTEM
K122956 FUSELOX LUMBAR INTERBODY FUSION DEVICE
K122989 BIOMET LATERAL SPACER SYSTEM
K122896 COUGAR LS 15 LATERAL CAGE SYSTEM
K121581 BOX PEEK VBR SYSTEM,
K120401 ALAMO T
K121567 ORACLE LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM
K122021 STERISPINE LC CAGE
K122591 CLYDESDALE SPINAL SYSTEM
K122047 ALAMO P
K122317 TETRIS II
K121760 CAPSTONE SPINAL SYSTEM
K121892 PHANTOM PLUS CERAMIC CAGE SYSTEM
K120991 TRANS1 INTERBODY FUSION SYSTEM
K121733 INFILL INTERVERTEBRAL BODY FUSION DEVICE
K121096 VENUS LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM
K121683 ACCULIF TL CAGE
K120966 DEPUY PULSE LUMBAR CAGE SYSTEM
K121333 WAVE D CAGE
K121332 LOOP CAGE
K121330 WAVE O CAGE
K121288 FUSE CAGE
K120918 NUVASIVE COROENT TITANIUM SYSTEM
K121246 MEDYSSY LT CAGE SYSTEM
K120203 TM-400 DEVICE
K121129 SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DEVICE
K113561 TM ARDIS INTERBODY SYSTEM TM ARDIS INTERBODY SYSTEM INSTRUMENATION
K110632 LUCENT OR LUCENT MAGNUM
K121116 PLATEAU SPACER SYSTEM
K112986 LATERAL FUSION DEVICE
K120063 VENUS LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM
K112696 TWIN PEAKS LUMBAR CAGE
K120368 CAPSTONE CONTROL SPINAL SYSTEM
K120576 ZAVATION IBF SYSTEM
K112648 ASFORA BULLET CAGE
K113540 RELIANCE LUMBAR IBF SYSTEM
K113478 PLIF CAGE
K111792 MOBIS, MOVAL, SEMIAL, TETRISMODEL PEEK AND TITANIUM, KIMBA MODEL STANDARD AND MINI
K120293 SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DRIVE
K120024 MECTALIF TRANSFORAMINAL
K113642 PERIMETER INTERBODY FUSION DEVICE
K111726 PATHWAY AVID
K113447 RISE SPACER
K113030 SPINEOLOGY PEEK BULLET LUMBAR INTERBODY FUSION DEVICE
K113527 OPTICAGE INTERBODY FUSION DEVICE
K113138 ALEUTIAN SYSTEM
K113528 CLYDESDALE(R) SPINAL SYSTEM
K112316 4-WEB ALIF SPINAL TRUSS SYSTEM (STS)
K113348 COUGAR SYSTEM
K113465 ACCULIF TL CAGE
K112095 ACCULIF TL-PEEK IBF CAGE
K112405 CLYDESDALES SPINAL SYSTEM
K110562 TELAMON PEEK SPINAL SYSTEM
K112359 PROW FUSION
K111512 BONEBAC T-PLIF INTERVERTEBRAL BODY FUSION DEVICE SYSTEM
K111965 VUSION(R) OS
K110783 VENUS INTERBODY FIXATION SYSTEM- VENUS PLIF/TLIF, ALIF PEEK CAGE
K112014 ZYSTON STRAIGHT SPACER SYSTEM
K111354 GS MEDICAL ANYPLUS PEEK LUMBAR CAGES (ALIF AND DLIF)
K110694 CONCORDE BULLET SPINAL SYSTEM
K112496 PIONEER CROSSFUSE II IBF/VBR SYSTEM
K111553 SPINEFRONTIER LUMBAR IBF SYSTEM
K111880 SPINEOLGY PEEK BULLET LUMBER INTERBODY FUSION DEVICE
K110659 MEDICAL CONCEPTS INTERBODY FUSION SYSTEM
K111166 A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE A.I.S.)
K111525 PERIMETER INTERBODY FUSION DEVICE
K110543 CRESCENT (R) SPINAL SYSTEM TITANIUM
K100305 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
K111774 PATHWAY MODEL 07XXXX
K103731 CAPSTONE R SPINAL SYSTEM
K111569 PLATEAU SPACER SYSTEM
K110650 ZYSTON ARC INTERBODY SPACER
K110843 ALEUTIAN SPACER SYSTEM
K110933 SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DEVICE
K110927 MECTALIF
K110226 INTERFUSE T INVERTEBRAL BODY FUSION DEVICE
K110454 COUGAR LS LATERAL CAGE SYSTEM
K102026 SEASPINE SPACER SYSTEM
K102957 CUTTING EDGE SPINE INTERBODY FUSION DEVICE
K110177 HELENA SYSTEM
K103729 INFILL INTERVERTEBRAL BODY FUSION DEVICE
K110067 LP CAGE
K110270 ACCULIF CAGE
K103666 LANX LATERAL
K103111 FORZA SPACER SYSTEM
K103814 PEZO INTERBODY CAGES SYSTEM
K103743 CONCORDE CURVE SYSTEM
K103488 CONCORDE BULLET CAGE SYSTEM
K100945 FUSE PLIF CAFE
K110045 INTERFUSE DA INVERTEBRAL BODY FUSION DEVICE
K103297 REDONDO-L
K083894 ALIF SPINAL TRUSS INTERBODY FUSION DEVICE
K102322 STINGRAY CERVICAL CAGE; SHARK IMPLANT (PLIF); BULL SHARK IMPLANT(PLIF); TIGER IMPLANT (TLIF); GREAT WHITE IMPLANTS(ALIF)
K103228 PARAMOUNT R IBF DEVICE
K102293 CALIBER SPACER
K103034 GENESYS SPINE INTERBODY FUSION SYSTEM
K102313 PATRIOT TRANSCONTINENTAL M SPACERS
K101923 CONCORDE CURVE SYSTEM
K102067 ENDOSKELETON TO
K102277 INTERFUSE T INVERTEBRAL BODY FUSION DEVICE
K100042 DIFUSION TECHNOLOGIES XIPHOS INTERBODY FUSION SYSTEM
K101301 STALIF MIDLINE
K100037 ADVANCED VERTEBRAL SOLUTIONS EXPRESS BFD
K100210 TRANS1 LATERAL INTERVERTEBRAL FUSION DEVICE, T
K101051 AVS A-LAT PEEK SPACERS, MODELS 48750XXX, 48751XXX, 48752XXX, 48753XXX
K100865 AVA NAVIGATOR PEEK SPACERS, MODEL 48392XXX, 48393XXX
K100743 ATLAS SPINE PIVOTING SYSTEM
K100820 WENZEL SPINE VARILIFT INTERBODY FUSION SYSTEM
K100544 IMPIX LUMBAR INTERBODY DEVICE
K101720 JULIET OL
K101085 SPINESMITH CYNCH SPINAL SYSTEM
K092815 S-LIF INTERVERTEBRAL BODY FUSION DEVICE
K100175 CLYDESDALE SPINAL SYSTEM
K083798 IMPIX ALIF LUMBAR IBF, IMPIX ALIF-D LUMBAR IBF, IMPIX TLIF LUMBAR IBF
K100089 SYNTHES T-PAL SPACER
K092901 EPICAGE INTERBODY FUSION DEVICE
K094025 CRESCENT SPINAL SYSTEM
K093669 SEC IBF CAGE
K093864 AVS ALIGN PEEK SPACERS MODEL 48328XXX, 48326XXX
K093015 BINDER INTERVERTEBRAL BODY FUSION DEVICE
K092574 ESL SPINAL SYSTEM
K092774 ATLAS INTERVERTEBRAL BODY CAGE
K091278 VALEO SPACER SYSTEM
K092162 4CIS PEEK, PLIF AND TLIF CAGE SYSTEM
K093704 AVS PL PEEK SPACERS
K093675 INTERFUSE INVERTEBRAL BODY FUSION DEVICE MODEL 9076
K093242 PATRIOT TRANSCONTINENTAL LLIF SPACER
K092017 PIVOTEC LUMBAR INTERBODY FUSION DEVICE (LIFD)
K083626 DISTRACTABLE WAVE CAGE
K090353 PERIMETER INTERBODY FUSION DEVICE
K092193 SPINAL USA INTERBODY CAGES
K091122 DIANA FUSION CAGE
K091638 DORADO WIDE INTERVERTEBRAL BODY CAGE, MODELS: IM2010-IM2031
K090048 ASFORA BULLET CAGE SYSTEM
K091381 IBEX SPINAL SYSTEM
K091988 MODIFICATION TO: INTERFUSE INTERVERTEBRAL BODY FUSION DEVICE , MODEL 9076
K090707 TALOS INTERVERTEBRAL BODY FUSION DEVICE
K090507 MODIFICATION TO LDR SPINE ROI INTERBODY FUSION SYSTEM; ROI-A IMPLANT SYSTEM
K090566 PATHWAY AVID
K081917 DEPUY SPINE BENGAL, CONCORDE, COUGAR, DEVEX AND LEOPARD SYSTEMS
K090899 DEPUY SPINE LATERAL SYSTEM
K090425 GUIDED LATERAL INTERBODY FUSION (GLIF) SYSTEM
K090816 STRYKER SPINE AVS PL PEEK SPACERS
K090782 NOVEL ALIF SPINAL SPACER SYSTEM
K090166 AVS ANTERIOR LARGE PEEK SPACERS
K082698 ALEUTIAN IBF SYSTEM
K083815 LANX FUSION SYSTEM
K083714 ENDOSKELETON TT INTERBODY FUSION DEVICE (IBD)
K090064 EMINENT SPINE INTERBODY FUSION SYSTEM
K090376 SPINESMITH CYNCH SPINAL SYSTEM
K083661 AVS TL PEEK SPACERS
K081888 DYNAMIK INTERVERTEBRAL BODY FUSION DEVICE
K082262 LDR SPINE ROI INTERBODY FUSION SYSTEM
K082406 EXPANDABLE PEEK-OPTIMA IMPLANT
K082712 THEKEN SPINE VU EPOD AND VU LPOD SYSTEM
K083026 CLYDESDALE SPINAL SYSTEM
K082128 DEPUY SPINE LATERAL CAGE SYSTEM
K081673 DYN-ALIF ANTEROLATERAL INTERVERTEBRAL BODY FUSION DEVICE
K082310 HOLLYWOOD, PACIFICA, REDONDO, VENTURA
K082774 LANX CERVICAL INTERVERTEBRAL BODY FUSION DEVICE
K082260 INTEGRA CERVICAL AND PETRA PLIF LUMBAR CAGES
K082732 MODIFICATION TO: CAPSTONE SPINAL SYSTEM
K081196 SPINAL USA VBR SYSTEM
K082270 OCTANE VERTEBRAL BODY REPLACEMENT (VBR) SYSTEM
K082342 MODIFICATION TO CAPSTONE SPINAL SYSTEM
K082235 BLACKSTONE PILLAR XL PEEK SPACERS
K081636 PEEK-OPTIMA ALIF SPACER
K081968 MODIFICATION TO LUCENT
K082014 STRYKER SPINE AVS PL PEEK SPACERS
K081177 BLACKSTONE MEDICAL, INC., PILLAR SPACER SYSTEM
K080537 L-VARLOCK
K080615 ENDOSKELETON TA INTERBODY FUSION DEVICE (IBD)
K080673 INTERFUSE INTERVERTEBRAL BODY FUSION DEVICE
K080588 SCIENT'X TRIBECA VBR
K080411 PLATEAU SPACER SYSTEM
K080314 SPINAL USA INTERBODY FUSION DEVICE
K073177 PIONEER INTERVERTEBRAL FUSION DEVICE SYSTEM
K080401 SHELL CAGE, WAVE CAGE, LOOP CAGE
K080281 PATHWAY
K071983 AESCULAP PEEK INTERVERTEBRAL BODY FUSION SYSTEM: A SPACE, CESPACE, PROSPACE, T-SPACE
K073440 FOUNDATION CAGE
K073291 CAPSTONE SPINAL SYSTEM
K080058 TURBO PRIME IBD SYSTEM
K080083 INTREPID SPINAL SYSTEM
K080758 AVS PL PEEK SPACERS, MODELS 48351 AND 48353
K073470 AVS PL PEEK SPACERS, MODELS 48351XXX AND 48353XXX
K073669 ORIA NATURA SPACER
K073202 ARDIS SPACER
K073144 LANX INTERVERTEBRAL BODY FUSION DEVICE
K072970 PATRIOT SPACERS
K073348 LUCENT MAGNUM
K072791 ORACLE SPACER, OPAL SPACER
K072226 IMPIX SPACER
K071795 NUVASIVE COROENT SYSTEM
K071724 LUCENT
K072289 SPINEFRONTIER DORADO VBR
K072120 PARAMOUNT INTERVERTEBRAL BODY FUSION DEVICE

FEI Numbers

This FDA classification entry is associated with 422 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 422 registration numbers. Click on an entry to view related FDA registrations.