BEUDAMED
    Product Code: ODP FDA class 2 21 CFR 888.3080

    Intervertebral Fusion Device With Bone Graft, Cervical

    Orthopedic

    The Intervertebral Fusion Device with Bone Graft for Cervical Spine (product code ODP) is an orthopedic implant used to stabilize the cervical spinal segment and promote fusion, thereby restricting motion and decreasing pain; it incorporates bone graft to facilitate the fusion process. The device is placed in the disc space following discectomy at one or more cervical levels. This device is FDA Class 2 under regulation 888.3080 in the Orthopedic specialty, requiring 510(k) clearance, and carries an implant flag indicating it remains in the body permanently. It carries no life-sustaining flag.

    View on FDA
    510(k)s
    349
    FEI Numbers
    339
    Registration Numbers
    339
    Unique Applicants
    203
    Years Active
    18

    Basic Information

    Product Code
    ODP
    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 cervical 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 349 510(k) clearances via K numbers.

    K Number Device Name
    K260840 BluEX Cervical Expandable Cage System
    K260850 OSTEOMNI SPINAL CAGES SYSTEM
    K260549 ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System
    K253260 ORIO-3D Cage System
    K260340 HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, HC BIOLOGICS OSTEOPOINT LUMBAR PEEK CAGES
    K242303 MOD-C
    K252240 Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System
    K252432 Flex-Z™ Cervical Cage
    K254105 Hive™ Standalone Cervical System and Hive™ C Interbody System
    K252205 Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody System; Curiteva Porous PEEK Laminoplasty System; Curiteva Porous PEEK Standalone ALIF System
    K254061 Curiteva Porous PEEK Cervical Interbody Fusion System
    K252219 Cervical Interbody and VBR Fusion System
    K252711 Advantage-C™ Ti3D Cervical Interbody Fusion Device
    K252894 aprevo® cervical interbody system
    K252781 MSFX MIKRON PEEK CAGES
    K250764 SpineLinc Anterior Cervical Implant System
    K250769 Dakota LP System
    K252686 EffortMed PEEK Cages & Corpectomy Cages
    K250560 BEE HA
    K252737 DeGen Medical Latitude-C AM Cervical Interbody Fusion System
    K250335 IVA & AEON Cervical and Lumbar Cage System
    K251080 IdentiTi II Cervical Interbody System
    K250605 EVOL® ha – Hyper C Cervical Interbody Fusion System
    K243915 FIX-C 3D Ti ACIF System
    K243673 Xenco Medical CancelleX Cervical Interbody System
    K242260 aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAM
    K242734 ZSFab Cervical Interbody System; ZSFab Lumbar Interbody System
    K242195 Gemini Cervical Fusion Cage System
    K241738 PYXIS 3D Titanium Cervical Cage system
    K240893 ARTFX MEDICAL Cervical PEEK Cages
    K240838 Spectrum Spine Cervical Cage System
    K241396 uCerv Flux™-C 3D Porous Titanium Cervical Interbody
    K232619 MATRIX HA PEEK Cervical IBF System
    K240416 Tranquil-C Interbody System
    K231371 BEE Cervical Cage
    K233839 Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT Intervertebral body fusion system; The Peridot-TD Anterior Cervical Intervertebral body fusion system; The Peridot-TD Intervertebral body fusion system
    K230639 Align Cervical Interbody Fusion System
    K233084 Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system
    K231836 ClariVy™ Cervical IBF System
    K230478 Acro Composites Interbody System
    K231899 HAtetracell™-C Titanium Cervical IBF System
    K232822 Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior cervical interbody fusion - ACIF (The Peridot-TD Anterior Cervical Intervertebral body fusion system)
    K231076 VariLift®-C Interbody Fusion System
    K222988 neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D Cervical
    K232150 ZSFab Cervical Interbody System
    K230607 SPICCA Cervical Fusion Cages
    K222874 CarboClear Cervical Cage System, CarboClear Cervical VBR System
    K231735 NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody System; NuVasive CoRoent Small Interlock System; NuVasive CoRoent Small Interlock II System; NuVasive CoRoent Small Ti-C System; NuVasive Cohere Cervical Interbody System
    K222015 Integral Titanium Cervical Interbody
    K230329 F3D Interbody System
    K230936 Anatomic PEEK™ Cervical Fusion System with Nanotechnology
    K230708 Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior cervical interbody fusion-ACIF (The Peridot-TD Anterior Cervical Intervertebral body fusion system)
    K222833 Ventana™ C Spinal System
    K230414 ClariVy™ Cervical IBF System
    K222004 INTEGRATE -C Interbody Fusion System
    K220513 NITRO Interbody Fusion Cage System Family
    K220261 NEST-C Interbody System
    K223513 UniVy™ OsteoVy™-Ti Cervical IBF System
    K230026 SQUALE
    K230583 Tryptik Ti
    K223043 The Integrity Spine Core System
    K223231 Ti-Largo Cervical Interbody System
    K213755 Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system
    K221490 Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior Lumbar Cage, Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar Cage, Stryker Spine VLIFT Vertebral Body Replacement System, VLIFT-s Vertebral Body Replacement System, Ascential IBD PEEKc Spacer, Aero-AL Lumbar Cage System, Aero-LL Lumbar Cage System, Aero-C Cervical Cage System, AVS Aria PEEK Spacer, AVS Anchor-C Cervical Cage System, AVS Anchor-L Spacer
    K213030 Curiteva Porous PEEK Cervical Interbody Fusion System
    K212701 Eminent Spine 3D Cervical Interbody Fusion System
    K220296 Manta Ray TDF Spacer
    K223731 NuVasive Modulus-C Interbody System
    K221266 Cervical Spine Truss System (CSTS) Interbody Fusion Device
    K222806 Kodiak C Spinal Implant System
    K223510 Matrix HA Fusion Porous Cervical IBF System
    K222973 IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System, IdentiTi NanoTec Cervical Interbody System, Transcend Cervical PEEK Interbody System, Transcend NanoTec Cervical Interbody System, IdentiTi Cervical Standalone Interbody System, IdentiTi NanoTec Cervical Standalone Interbody Sytem
    K221162 UniVy OsteoVy Cervical IBF System
    K222270 HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS Instruments
    K222276 CONDUIT Cages; FIBERGRAFT BG Putty
    K220875 HAcancellous PEEK-C Porous HA PEEK Cervical IBF System
    K220696 uCerv Flux-C 3D Porous Titanium Cervical Interbody
    K212450 Keos Anterior Cervical Interbody Fusion Device System
    K202266 Reliance Cervical IBF System
    K213980 Peridot Spinal Interbody System
    K213493 Fortilink with TiPlus Technology
    K212266 FIX-C PEEK Anterior Cervical Interbody System
    K212715 Vy Spine ClariVy Cervical IBF System
    K213115 CHENA-C Spacer System
    K211935 ORIO-Ti Intervertebral Body Fusion Cage System
    K212792 Medynus IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage
    K201793 EDEN Peek Cage
    K211704 CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer System, CONSTRUX Mini Ti Spacer System, FORZA PEEK Spacer System, FORZA PTC Spacer System, FORZA Ti Spacer System, FORZA XP Expandable Spacer System, Lonestar Cervical Standalone System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, PILLAR SA PTC Spacer System, SKYHAWK Lateral Interbody Fusion System
    K212038 K&J IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage
    K211501 Advantage-C PEEK Cervical lnterbody Fusion Device
    K210521 DEXA-C Cervical Interbody System
    K210890 GPS Cervical Spacers
    K203520 Blustone Synergy Interbody Fusion System
    K203444 BEE HA Cage
    K203342 CONSTRUX Mini Ti Spacer System
    K202872 Prase PEEK Anterior Cervical Interbody Spacer
    K202398 Ti3Z Cervical Interbody System
    K200429 BEE Cages
    K202488 ZSFab Cervical Interbody System
    K200458 Tailored-C Cervical Interbody Fusion System
    K201643 ChoiceSpine Tiger Shark Cervical Spacer System
    K200549 Lucero Medical Cervical Cage System
    K202302 Atlas Spine Rebar (Ti) Spacer System
    K202949 CONSTRUX Mini PEEK Spacer System
    K202666 CONSTRUX Mini PTC Spacer System
    K201506 Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical Intervertebral Body Fusion System
    K201769 Cavetto [MAX] Cervical Cage System
    K200592 GS Medical AnyPlus PEEK Cage System
    K200685 RIGEL 3DR Anterior Cervical Interbody Fusion System
    K200052 CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer System
    K200312 Tryptik Ti
    K192897 icotec Cervical Cage
    K193359 SureMAX Family of Cervical Spacers
    K192044 4CIS Marlin PEEK ACIF Cage
    K191812 ADI Cervical Interbody Fusion Device
    K192316 Matrix HA PEEK Cervical Implant System
    K191822 Nano FortiCore, FortiCore
    K192208 CORNICE Cervical Spacer System
    K191537 eCarbon IBDs
    K191243 HEDRON Cervical Spacers
    K191354 Ti3Z Cervical Interbody System
    K192018 Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic Interbody Fusion Device, Endoskeleton TO Interbody Fusion Device, Endoskeleton TT Interbody Fusion Device, Endoskeleton TC Interbody Fusion Device, Endoskeleton TCS Interbody Fusion Device, Endoskeleton TL Interbody Fusion Device
    K191621 ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer System Ascendant PC, ChoiceSpine Cervical Interbody Spacer System Ascendant, ChoiceSpine Cervical Spacer System Blackhawk, ChoiceSpine Intervertebral Fusion Device Octane Straight, ChoiceSpine Intervertebral Fusion Device Octane Straight PC, ChoiceSpine VEO Laterial Access & Interbody Fusion System
    K190291 Addivation Medical Cervical Interbody System
    K190889 Republic Spine Restore Cervical Interbody Fusion System
    K182608 Oyster ACIF Cage
    K190618 RIGEL PEEK Anterior Cervical Interbody Fusion System
    K190380 nvc
    K183397 ChoiceSpine Stealth Cervical Spacer System
    K190322 SCARLET® AC-T Secured Anterior Cervical Cage
    K183083 Shoreline Cervical Interbody RT System
    K183557 Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TO Interbody Fusion Device, Endoskeleton® TT Interbody Fusion Device, Endoskeleton® TC Interbody Fusion Device, Endoskeleton® TCS Interbody Fusion Device, Endoskeleton® TL Interbody Fusion Device, Endoskeleton® TA Vertebral Body Replacement (VBR) Device
    K190067 Velofix Interbody Fusion System
    K182477 Cervical Spacer
    K182284 Tyber Medical PT Interbody Spacer
    K180909 REVEL Spacers
    K181140 Axis Chena Cervical PEEK Spacer System
    K181590 Neurostructures Cavetto® [MAX] Cervical Cage System
    K181229 TirboLOX-C Cervical IBFD
    K181471 ACCUFUSE Cervical System
    K181435 ATEC Cervical Spacer System
    K181115 CxHA PEEK Cervical IBF System
    K181261 Curiteva Cervical Interbody Fusion System
    K180590 Tyber Medical PT Interbody Spacer System
    K180364 HD LifeSciences Cervical IBFD System
    K180674 EVOL® ha-C Cervical Interbody Fusion System
    K172788 MONET™ Anterior Cervical Interbody Fusion Cage System
    K180401 TiWAVE-C™ Porous Titanium Cervical Cage
    K180675 Atlas Spine Expandable Cervical Interbody System
    K173722 PATRIOT COLONIAL Spacer, SUSTAIN Spacer
    K173832 InTice™-C Porous Ti Cervical Interbody System
    K172480 icotec Interbody Cage System
    K172568 Cervage
    K173128 Alamo® C
    K173453 Valeo® C+CSC with Lumen Interbody Fusion Device
    K173324 ALTA Anterior Cervical Interbody Spacer
    K172320 Neurostructures Cavetto® Cervical Cage System
    K173535 Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody Fusion Device and Endoskeleton® TCS Interbody Fusion Device
    K172212 MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™
    K173159 Cervical Spinal Truss System (CSTS) Interbody Fusion Device
    K173102 Reliance Cervical IBF System
    K172926 SeaSpine Vu cPOD, Zuma-C, Complete Cervical
    K172185 Tyber Medical PT Interbody Spacer System
    K173115 COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and COALITION AGX® TPS
    K172676 NuVasive® Modulus-C Interbody System
    K173148 ACIF
    K173030 Vertera Spine Cohere Cervical Interbody Fusion Device
    K172253 Altus Spine Cervical Interbody Fusion System
    K172446 SPIRA-C Open Matrix Cervical Interbody
    K172674 Sapphire Cervical Implant System
    K172437 CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer System
    K172065 SCARLET AC-T
    K172587 Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markers
    K163422 Shanghai Sanyou PEEK Cage System
    K172489 Reliance Cervical IBF System
    K171496 Tritanium C Anterior Cervical Cage
    K171140 Matrixx System
    K171075 Calix-C Cervical Interbody Spacer
    K171749 Velofix(tm) Interbody Fusion System
    K170550 Coveris Cervical Cage System
    K170318 NeoFuse Ti3D PLIF/TLIF/Cervical Interbody
    K171046 SeaSpine Cambria System
    K170844 Gemini-C Hybrid Cervical Interbody System
    K163494 Summit Spine Channel Cervical Interbody Fusion System
    K162682 MATISSE Anterior Cervical Interbody Fusion Cage System
    K163673 Fortilink™-C with TETRAfuse™ 3D Technology
    K162496 Foundation 3D Interbody
    K163265 Kepler II
    K163491 NuVasive CoRoent Small Interbody System
    K162402 4CIS® Marlin ACIF Cage System
    K162587 ROCCIA® ACIF
    K170074 nvc
    K162694 Ayers Rock Cervical interbody fusion system
    K161127 The Small PLATEAU (PLATEAU-C) Spacer System
    K162003 IMSE Cervical Cage
    K160222 OIC Cervical PEEK Spacer
    K161809 ShurFit CpTi-HA ACIF Interbody Fusion System
    K162220 DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) Cage
    K161649 Virtu C Spinal Implant System
    K162138 NuVasive CoRoent Small Ti-C System
    K161642 CAVUX™ Cervical Cage
    K161608 InterForm Cervical Interbody Cage System
    K161407 Ascential IBD PEEKc Spacer
    K153517 AnyPlus® Cervical PEEK Cage System
    K160154 ALTA Anterior Cervical Interbody Spacer
    K160324 Cervical Interbody Fusion System
    K160125 Cascadia Interbody System
    K160528 ANATOMIC PEEK PTC Cervical Fusion System
    K153438 PERIMETER C (Titanium) Spinal System
    K153373 CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical Interbody Device
    K152532 AERO -C Cervical Cage System
    K151496 Latitude-C Cervical Interbody Spacer System
    K152987 Xenco Medical Cervical Interbody System, Xenco Medical Lumbar Interbody System
    K150455 RT2 Trabeculite Titanium Cervical Cage System
    K150788 Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion Devices, Talos -C(HA) Cervical Intervertebral Body Fusion Devices
    K143685 Hedgehog Cervical Interbody Fusion Device
    K143450 Ackermann Intervertebral Body Fusion Device
    K150619 CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer System
    K152302 Xenco Medical Cervical Interbody System (Argus)
    K150812 Genesys Spine Apache Cervical Interbody Fusion System
    K150847 Foundation Interbody Devices
    K151677 LnK Cervical Interbody Fusion Cage System
    K150362 NuVasive CoRoent Small Interbody System
    K143572 Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance Device - DIMEI PEEK, Intersomatic Transforaminal - TLIF PEEK
    K142269 Reliance Cervical IBF System
    K150130 Ascendant TM Cervical Spacer System
    K142586 Captiva Spine FuselOX Cervical IBF System
    K150521 Interbody Fusion (IBF)/Vertebral Body Replacement(VBR) System
    K142744 Mecta-C TiPEEK
    K142456 GPS Spacers
    K143360 LnK Cervical Interbody Fusion Cage System
    K142218 Coalition AGX Plate and Coalition AGX Spacer
    K142345 Talos-C(HA) Cervical Intervertebral Body Fusion Devices
    K142152 CONSTRUX MINI PEEK; SPACER SYSTEM, TI SPACER SYSTEM, CERVICAL STAND ALONE SYSTEM
    K142328 nvc
    K142041 POROSTEON PHUSION METAL CERVICAL CAGE
    K142264 Valeo C Spacer System, Valeo II C IBF Device
    K141333 ARENA-C TIFUSE CERVICAL INTERVERTEBRAL BODY FUSION DEVICE
    K142251 AVS AS PEEK Spacer
    K142050 NUVASIVE COROENT SMALL CONTOURED INTERBODY SYSTEM
    K142026 SPINEFRONTIER ARENA-C HA PEEK CERVICAL INTERVERTEBRAL BODY FUSION DEVICE
    K142450 DIVERGENCE Anterior Cervical Fusion System
    K141337 ARENA-C
    K140280 FORTICORE
    K140786 XENCO MEDICAL CERVICAL INTERBODY SYSTEM
    K141129 EXACTECH CERVICAL SPACER SYSTEM
    K140921 COROENT SMALL INTERBODY SYSTEM
    K140864 VELOXTM INTERBODY FUSION SYSTEM
    K132732 MEDYSSEY ANTERIOR CERVICAL FUSION CAGE
    K133784 VISTA-S DEVICE, ASSOCIATED INSTRUMENTATION
    K140066 INFILL CERVICAL
    K133653 ANATOMIC PEEK PTC CERVICAL FUSION SYSTEM
    K133815 INTESS CERVICAL CAGE SYSTEM
    K140003 COROENT SMALL INTERBODY SYSTEM
    K132483 INNESIS PEEK CERVICAL CAGE
    K133529 CAMBER SPINE COVERIS CERVICAL CAGE
    K132926 VELOFIXTM INTERBODY FUSION SYSTEM
    K132991 C-BOX PEEK CERVICAL IBF
    K133623 C-PLUS
    K133321 ALAMO C
    K130317 GENESYS SPINE APACHE IBFD STAR CERVICAL SYSTEM
    K132584 PERIMETER C SPINAL SYSTEM
    K132718 INTEGRITY SPINE CORE SYSTEM
    K130853 IDYS(TM) C
    K130573 TYBER MEDICAL INTERBODY SYSTEM; ACIF, ALIF, PLIF, TLIF, DLIF
    K131429 RELIANCE CERVICAL IBF SYSTEM
    K130177 ANATOMIC PEEK CERVICAL FUSION SYSTEM
    K130948 C-FUSE CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM
    K121178 TRANSCORP ACIF SYSTEM
    K122588 VUSION CS PLUS
    K122801 PROVIDENCE CERVICAL CAGE
    K123909 AESCULAP CESPACE XP
    K122850 TALOS-C CERVICAL INTERVERTEBRAL BODY FUSION DEVICES
    K122872 INTERVERTEBRAL BODY FUSION DEVICE
    K122518 SYNSTER (CERVICAL,ALIF, PLIF, PTLIF AND TLIF) CAGE HERA CERVICAL CAGE RHEA PLIF CAGE TALON TIFA CAGE
    K123206 MAXIM SURGICAL X-TREME INTERBODY FUSION SYSTEM
    K120603 VARILIFT -C
    K123388 K7C SPACER
    K121649 CONSTRUX MINI PEEK TI SPACER SYSTEM
    K121741 4-WEB CERVICAL STS (SPINAL TRUSS SYSTEM)
    K122085 STINGRAY CERVICAL CAGE
    K122366 TRYPTIK CC ANTERIOR INTERSOMATIC CERVICAL CAGE
    K122444 CERVICAL CAGE
    K120486 AVS AS PEEK SPACER
    K121320 C7 ANTERIOR CERVICAL INTERVERTEBRAL FUSION CAGE
    K121569 MATISSE ANTERIOR CERVICAL INTERBODY FUSION CAGE SYSTEM
    K120345 HONOUR SPACER SYSTEM
    K120275 SYNTHES ACIS/VERTEBRAL SPACER CR
    K120840 LEXUS CERVICAL INTERVERTEBRAL BODY FUSION CAGE SYSTEM
    K120396 RELIANCE CERVICAL IBF SYSTEM
    K112801 AYERS ROCK CERVICAL CAGE
    K120517 DEPUY PULSE CERVICAL CAGE SYSTEM
    K111820 SYNSTER CERVICAL CAGE, ALIF CAGE, PLIF CAGE, PTLIF CAGE, TLIF CAGE
    K120143 ECLIPSE VERTEBRAL SPACER SYSTEM-CERVICAL
    K113518 ARENA-C CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM
    K113559 LDR SPINE CERVICAL INTERBODY FUSION SYSTME-ROI-C LORDOTIC IMPLANTS
    K112664 ZAVATION IBF SYSTEMS
    K112862 MECTA-C
    K111123 VARILIFT CERVICAL INTERBODY FUSION SYSTEM
    K112361 ALAMO C
    K111119 TRABECULAR METAL (TM) FUSION DEVICE
    K111983 VISTA-S DEVICE MODEL 08/06-401-XXXXX, 08/06-402-XXXXXX
    K112444 ANATOMIC PEEK CERVICAL FUSION SYSTEM
    K110442 NANOVIS INTERVERTEBRAL BODY FUSION SYSTEM
    K112036 CALIX PC SPINAL IMPLANT SYSTEM
    K111264 CORNERSTONE (R) PSR CERVICAL FUSION SYSTEM
    K111484 DISCOVERY
    K110733 DAYTONA ANTERIOR CERVICAL CAGE
    K100967 PERIMETER C SPINAL SYSTEM
    K111675 VU C*POD INTERVERTEBRAL BODY FUSION DEVICE
    K110915 CERVICAL CAGE
    K111835 PLATEAU SPACER SYSTEM
    K103655 OCTANE-C INTERBODY FUSION DEVICE SYSTEM
    K110585 CAPTIVA SPINE FUSELOX CERVICAL CAGE
    K100698 STCC
    K103169 ALEUTTIAN
    K103660 LANX CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM
    K102449 BRIGHT SPINE GALILEO SPINAL SPACER SYSTEM
    K101171 ORTHOVITA PEEK SPACER
    K103033 TRABECULAR METAL FUSION DEVICE MODEL 06-101-XXXXX, 06-102-XXXXX AND 08-100-XXXXX
    K101363 VU CPOD INTERVERTEBRAL BODU FUSION DEVICE
    K093093 SMALL PLATEAU SPACER SYSTEM
    K101812 CONSTRUX MINI PEEK SPACER SYSTEM
    K092794 TRANSCORP ACIF SYSTEM
    K100889 ENDOSKELETON TC
    K101302 ALEUTIAN IBF SYSTEM
    K100214 CORNERSTONE PSR CERVICAL INTERBODY FUSION DEVICE
    K100484 IMPIX MANTA CERVICAL INTERBODY DEVICE
    K092540 C-PS PEEK OPTIMA CERVICAL INTERBODY SPACER, L-PS PEEK OPTIMA LUMBAR INTERBODY SPACER
    K092904 PATHWAY IVB/VBR
    K091531 CHOICE SPINE CERVICAL INTERBODY SPACER SYSTEM CHOICE SPINE CERVICAL INTERBODY SPACER
    K090887 ORIO-C CERVICAL, ORIO-TL TLIF, ORIO-PL PLIF, ORIO-AL ALIF INTERVEDRTEBRAL BODY FUSION CAGES
    K091873 TRYPTIK CA ANTERIOR INTERSOMATIC CERVICAL CAGE, MODELS MOS-CA 12 05-S, MOS-CA 12 O6-S
    K082848 NUBIC AND RABEA DEVICES
    K091088 LDR SPINE CERVICAL INTERBODY FUSION SYSTEM
    K083118 SPINAL USA ANTERIOR CERVICAL INTERBODY FUSION DEVICE
    K083637 CALIX SPINAL IMPLANT SYSTEM
    K082309 CAMBRIA
    K083425 FUSION ADVANTAGE CERVICAL CAGE, FUSION ADVANTAGE LUMBAR CAGE
    K083311 AESCULAP CESPACE PEEK INTERVERTEBRAL BODY FUSION SYSTEM
    K083167 PHENIX CERVICAL INTERBODY DEVICE
    K082801 PHANTOM PLUS CAGE SYSTEM
    K081880 ATLAS SPINE SPACER
    K081611 NUVASIVE COROENT SYSTEM
    K081730 NOVEL CERVICAL SPINAL SPACER SYSTEM
    K081614 ZEUS SMALL CERVICAL CAGE AND LARGE, EXTRA LARGE, CURVED AND STRAIGHT LUMBAR CAGES
    K073320 CIMPLICITY SPINAL SYSTEM
    K073351 CRYSTAL
    K072991 PATRIOT SPACERS: COLONIAL ACDF

    FEI Numbers

    This FDA classification entry is associated with 339 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 339 registration numbers. Click on an entry to view related FDA registrations.