ODP · Intervertebral Fusion Device With Bone Graft, Cervical
Orthopedic · 21 CFR 888.3080 · Class 2
Overview
| Product Code | ODP |
|---|---|
| Device Name | Intervertebral Fusion Device With Bone Graft, Cervical |
| Regulation | 21 CFR 888.3080 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.
Classification Rationale
(1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
Special Controls
*Classification.* (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval. (c) *Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
Cleared Devices (346)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253260 | ORIO-3D Cage System | SpineCraft | Apr 16, 2026 | SESE |
| K260340 | HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, HC BIOLOGICS OSTEOPOINT LUMBAR PEEK CAGES | HC Biologics, LLC | Apr 13, 2026 | SESE |
| K242303 | MOD-C | Orthomod, LLC | Apr 1, 2026 | SESE |
| K252240 | Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System | Spectrum Spine | Mar 30, 2026 | SESE |
| K252432 | Flex-Z Cervical Cage | Spinepoint, LLC | Mar 25, 2026 | SESE |
| K254105 | Hive Standalone Cervical System and Hive C Interbody System | NanoHive Medical, LLC | Feb 13, 2026 | SESE |
| K252205 | Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody System; Curiteva Porous PEEK Laminoplasty System; Curiteva Porous PEEK Standalone ALIF System | Curiteva, Inc. | Jan 16, 2026 | SESE |
| K254061 | Curiteva Porous PEEK Cervical Interbody Fusion System | Curiteva, Inc. | Jan 15, 2026 | SESE |
| K252219 | Cervical Interbody and VBR Fusion System | Sync Surgical | Jan 14, 2026 | SESE |
| K252711 | Advantage-C Ti3D Cervical Interbody Fusion Device | Intelivation Technologies | Jan 8, 2026 | SESE |
| K252894 | aprevo® cervical interbody system | Carlsmed, Inc. | Jan 6, 2026 | SESE |
| K252781 | MSFX MIKRON PEEK CAGES | Mikron Makina Sanayi VE Tic. Ltd. Sti. | Dec 19, 2025 | SESE |
| K250764 | SpineLinc Anterior Cervical Implant System | Lincotek Medical | Dec 5, 2025 | SESE |
| K250769 | Dakota LP System | Precision Spine, Inc. | Nov 24, 2025 | SESE |
| K252686 | EffortMed PEEK Cages & Corpectomy Cages | Effortmed, LLC | Nov 21, 2025 | SESE |
| K250560 | BEE HA | NGMedical GmbH | Nov 21, 2025 | SESE |
| K252737 | DeGen Medical Latitude-C AM Cervical Interbody Fusion System | Degen Medical | Oct 10, 2025 | SESE |
| K250335 | IVA & AEON Cervical and Lumbar Cage System | K&J Consulting | Aug 29, 2025 | SESE |
| K251080 | IdentiTi II Cervical Interbody System | Alphatec Spine, Inc. | Jul 3, 2025 | SESE |
| K250605 | EVOL® ha Hyper C Cervical Interbody Fusion System | Cutting Edge Spine, LLC | Mar 12, 2025 | SESE |
| K243915 | FIX-C 3D Ti ACIF System | Jeil Medical Corporation | Feb 18, 2025 | SESE |
| K243673 | Xenco Medical CancelleX Cervical Interbody System | Xenco Medical, LLC | Jan 29, 2025 | SESE |
| K242260 | aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAM | Carlsmed, Inc. | Nov 15, 2024 | SESE |
| K242734 | ZSFab Cervical Interbody System; ZSFab Lumbar Interbody System | Zsfab | Nov 7, 2024 | SESE |
| K242195 | Gemini Cervical Fusion Cage System | ZheJiang Decans Medical Devices Co., Ltd. | Nov 4, 2024 | SESE |
| K241738 | PYXIS 3D Titanium Cervical Cage system | GS Medical Co., Ltd. | Aug 20, 2024 | SESE |
| K240893 | ARTFX MEDICAL Cervical PEEK Cages | Artfx Medical | Jun 28, 2024 | SESE |
| K240838 | Spectrum Spine Cervical Cage System | Spectrum Spine, Inc. | May 30, 2024 | SESE |
| K241396 | uCerv Flux-C 3D Porous Titanium Cervical Interbody | Ulrich Medical USA, Inc. | May 23, 2024 | SESE |
| K232619 | MATRIX HA PEEK Cervical IBF System | Sapphire Medical Group | Mar 19, 2024 | SESE |
| K240416 | Tranquil-C Interbody System | Nexus Spine, LLC | Mar 12, 2024 | SESE |
| K231371 | BEE Cervical Cage | NGMedical GmbH | Jan 12, 2024 | SESE |
| 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 | Gbs Commonwealth Co., Ltd. | Dec 20, 2023 | SESE |
| K230639 | Align Cervical Interbody Fusion System | Acuity Surgical Devices, LLC | Dec 1, 2023 | SESE |
| K233084 | Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system | Gbs Commonwealth Co., Ltd. | Nov 21, 2023 | SESE |
| K231836 | ClariVy Cervical IBF System | Vy Spine, LLC | Oct 30, 2023 | SESE |
| K230478 | Acro Composites Interbody System | Acro Composites, LLC | Oct 19, 2023 | SESE |
| K231899 | HAtetracell-C Titanium Cervical IBF System | Innovasis, Inc. | Oct 17, 2023 | SESE |
| 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) | Gbs Commonwealth Co., Ltd. | Oct 13, 2023 | SESE |
| K231076 | VariLift®-C Interbody Fusion System | Wenzel Spine, Inc. | Sep 27, 2023 | SESE |
| K222988 | neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D Cervical | Ht Medical D.B.A. Xenix Medical | Sep 1, 2023 | SESE |
| K232150 | ZSFab Cervical Interbody System | Zsfab, Inc. | Aug 18, 2023 | SESE |
| K230607 | SPICCA Cervical Fusion Cages | Southern Medical (Pty) , Ltd. | Aug 14, 2023 | SESE |
| K222874 | CarboClear Cervical Cage System, CarboClear Cervical VBR System | Carbofix Orthpedics , Ltd. | Jul 26, 2023 | SESE |
| 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 | Nu Vasive, Incorporated | Jul 11, 2023 | SESE |
| K222015 | Integral Titanium Cervical Interbody | Nvision Biomedical Technologies, Inc. | Jul 5, 2023 | SESE |
| K230329 | F3D Interbody System | Corelink, LLC | Jun 6, 2023 | SESE |
| K230936 | Anatomic PEEK Cervical Fusion System with Nanotechnology | Nanovis, LLC | Jun 2, 2023 | SESE |
| 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) | Gbs Commonwealth Co., Ltd. | May 22, 2023 | SESE |
| K222833 | Ventana C Spinal System | Spinal Elements, Inc. | May 19, 2023 | SESE |
| K230414 | ClariVy Cervical IBF System | Vy Spine, LLC | May 12, 2023 | SESE |
| K222004 | INTEGRATE -C Interbody Fusion System | Happe Spine | Apr 28, 2023 | SESE |
| K220513 | NITRO Interbody Fusion Cage System Family | Ctl Medical Corporation | Apr 25, 2023 | SESE |
| K220261 | NEST-C Interbody System | Paonan Biotech Co., Ltd. | Apr 24, 2023 | SESE |
| K223513 | UniVy OsteoVy-Ti Cervical IBF System | Vy Spine, LLC | Apr 18, 2023 | SESE |
| K230026 | SQUALE | Implanet, S.A. | Mar 28, 2023 | SESE |
| K230583 | Tryptik Ti | Spineart SA | Mar 22, 2023 | SESE |
| K223043 | The Integrity Spine Core System | Integrity Spine | Mar 20, 2023 | SESE |
| K223231 | Ti-Largo Cervical Interbody System | Flospine | Feb 24, 2023 | SESE |
| K213755 | Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system | Gbs Commonwealth Co., Ltd. | Feb 17, 2023 | SESE |
| 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 | Stryker Spine | Feb 14, 2023 | SESE |
| K213030 | Curiteva Porous PEEK Cervical Interbody Fusion System | Curiteva, Inc. | Feb 13, 2023 | SESE |
| K212701 | Eminent Spine 3D Cervical Interbody Fusion System | Eminent Spine | Feb 6, 2023 | SESE |
| K220296 | Manta Ray TDF Spacer | SeaSpine Orthopedics Corporation | Feb 3, 2023 | SESE |
| K223731 | NuVasive Modulus-C Interbody System | Nuvasive, Inc. | Jan 12, 2023 | SESE |
| K221266 | Cervical Spine Truss System (CSTS) Interbody Fusion Device | 4Web Medical, Inc. | Jan 5, 2023 | SESE |
| K222806 | Kodiak C Spinal Implant System | Met One Technologies, LLC | Dec 22, 2022 | SESE |
| K223510 | Matrix HA Fusion Porous Cervical IBF System | Innovasis, Inc. | Dec 12, 2022 | SESE |
| 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 | Alphatec Spine, Inc. | Nov 17, 2022 | SESE |
| K221162 | UniVy OsteoVy Cervical IBF System | Vy Spine, LLC | Nov 4, 2022 | SESE |
| K222270 | HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS Instruments | Globus Medical, Inc. | Oct 21, 2022 | SESE |
| K222276 | CONDUIT Cages; FIBERGRAFT BG Putty | Depuy Spine | Oct 15, 2022 | SESE |
| K220875 | HAcancellous PEEK-C Porous HA PEEK Cervical IBF System | Innovasis, Inc. | Aug 26, 2022 | SESE |
| K220696 | uCerv Flux-C 3D Porous Titanium Cervical Interbody | Ulrich Medical USA | Aug 19, 2022 | SESE |
| K212450 | Keos Anterior Cervical Interbody Fusion Device System | Keos | Jun 6, 2022 | SESE |
| K202266 | Reliance Cervical IBF System | Reliance Medical Systems, LLC | Mar 29, 2022 | SESE |
| K213980 | Peridot Spinal Interbody System | Gbs Commonwealth Co., Ltd. | Mar 15, 2022 | SESE |
| K213493 | Fortilink with TiPlus Technology | Paradigm Spine | Jan 27, 2022 | SESE |
| K212266 | FIX-C PEEK Anterior Cervical Interbody System | Jeil Medical Corporation | Dec 21, 2021 | SESE |
| K212715 | Vy Spine ClariVy Cervical IBF System | Vy Spine, LLC | Dec 20, 2021 | SESE |
| K213115 | CHENA-C Spacer System | Kahtnu Surgical, Inc. | Dec 6, 2021 | SESE |
| K211935 | ORIO-Ti Intervertebral Body Fusion Cage System | Spinecraft, LLC | Sep 30, 2021 | SESE |
| K212792 | Medynus IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage | Medynus, Inc. | Sep 23, 2021 | SESE |
| K201793 | EDEN Peek Cage | Jmt Co., Ltd. | Sep 13, 2021 | SESE |
| 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 | Orthofix, Inc. | Aug 31, 2021 | SESE |
| K212038 | K&J IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage | K&J Consulting Corporation | Aug 27, 2021 | SESE |
| K211501 | Advantage-C PEEK Cervical lnterbody Fusion Device | Lntelivation, LLC | Aug 24, 2021 | SESE |
| K210521 | DEXA-C Cervical Interbody System | Aurora Spine, Inc. | Aug 2, 2021 | SESE |
| K210890 | GPS Cervical Spacers | G Surgical, LLC | Apr 23, 2021 | SESE |
| K203520 | Blustone Synergy Interbody Fusion System | Blustone Synergy, LLC | Apr 7, 2021 | SESE |
| K203444 | BEE HA Cage | NGMedical GmbH | Mar 18, 2021 | SESE |
| K203342 | CONSTRUX Mini Ti Spacer System | Orthofix, Inc. | Mar 18, 2021 | SESE |
| K202872 | Prase PEEK Anterior Cervical Interbody Spacer | Gbs Commonwealth Co., Ltd. | Feb 4, 2021 | SESE |
| K202398 | Ti3Z Cervical Interbody System | Zavation Medical Products, LLC | Jan 29, 2021 | SESE |
| K200429 | BEE Cages | NGMedical GmbH | Jan 29, 2021 | SESE |
| K202488 | ZSFab Cervical Interbody System | Zsfab, Inc. | Jan 7, 2021 | SESE |
| K200458 | Tailored-C Cervical Interbody Fusion System | Bespoke Technologies | Dec 28, 2020 | SESE |
| K201643 | ChoiceSpine Tiger Shark Cervical Spacer System | Choice Spine, LLC | Dec 22, 2020 | SESE |
| K200549 | Lucero Medical Cervical Cage System | Lucero Medical, LLC | Dec 16, 2020 | SESE |
| K202302 | Atlas Spine Rebar (Ti) Spacer System | Atlas Spine, Inc. | Oct 30, 2020 | SESE |
| K202949 | CONSTRUX Mini PEEK Spacer System | Orthofix, Inc. | Oct 29, 2020 | SESE |
| K202666 | CONSTRUX Mini PTC Spacer System | Orthofix, Inc. | Oct 14, 2020 | SESE |
| K201506 | Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical Intervertebral Body Fusion System | Meditech Spine, LLC | Sep 11, 2020 | SESE |
| K201769 | Cavetto [MAX] Cervical Cage System | Neurostructures, Inc. | Sep 3, 2020 | SESE |
| K200592 | GS Medical AnyPlus PEEK Cage System | GS Medical Co., Ltd. | Aug 10, 2020 | SESE |
| K200685 | RIGEL 3DR Anterior Cervical Interbody Fusion System | MiRus, LLC | Jun 11, 2020 | SESE |
| K200052 | CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer System | Orthofix, Inc. | Apr 9, 2020 | SESE |
| K200312 | Tryptik Ti | Spineart | Apr 6, 2020 | SESE |
| K192897 | icotec Cervical Cage | Icotec AG | Mar 20, 2020 | SESE |
| K193359 | SureMAX Family of Cervical Spacers | Additive Implants, Inc. | Jan 3, 2020 | SESE |
| K192044 | 4CIS Marlin PEEK ACIF Cage | Solco Biomedical Co., Ltd. | Dec 19, 2019 | SESE |
| K191812 | ADI Cervical Interbody Fusion Device | Additive Device, Inc. (Adi) D/B/A Restor3D | Oct 24, 2019 | SESE |
| K192316 | Matrix HA PEEK Cervical Implant System | Sapphire Medical Group | Oct 17, 2019 | SESE |
| K191822 | Nano FortiCore, FortiCore | Nanovis, LLC | Oct 11, 2019 | SESE |
| K192208 | CORNICE Cervical Spacer System | Legend Spine Technologies | Oct 9, 2019 | SESE |
| K191537 | eCarbon IBDs | Back 2 Basics Direct, LLC | Sep 26, 2019 | SESE |
| K191243 | HEDRON Cervical Spacers | Globus Medical, Inc. | Sep 17, 2019 | SESE |
| K191354 | Ti3Z Cervical Interbody System | Zavation Medical Products, LLC | Sep 9, 2019 | SESE |
| 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 | Titan Spine, Inc. | Aug 16, 2019 | SESE |
| 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 | Choice Spine, LLC | Aug 15, 2019 | SESE |
| K190291 | Addivation Medical Cervical Interbody System | Addivation Medical, LLC | Jul 30, 2019 | SESE |
| K190889 | Republic Spine Restore Cervical Interbody Fusion System | Republic Spine, LLC | Jun 19, 2019 | SESE |
| K182608 | Oyster ACIF Cage | Silony Medical GmbH | Jun 13, 2019 | SESE |
| K190618 | RIGEL PEEK Anterior Cervical Interbody Fusion System | MiRus, LLC | Jun 6, 2019 | SESE |
| K190380 | nvc | Nvision Biomedical Technologies, Inc. | Mar 21, 2019 | SESE |
| K183397 | ChoiceSpine Stealth Cervical Spacer System | Choicespine, LP | Mar 6, 2019 | SESE |
| K190322 | SCARLET® AC-T Secured Anterior Cervical Cage | Spineart | Mar 4, 2019 | SESE |
| K183083 | Shoreline Cervical Interbody RT System | SeaSpine Orthopedics Corporation | Feb 14, 2019 | SESE |
| 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 | Titan Spine, Inc. | Feb 11, 2019 | SESE |
| K190067 | Velofix Interbody Fusion System | U&I Corporation | Feb 4, 2019 | SESE |
| K182477 | Cervical Spacer | Additive Implants, LLC | Jan 28, 2019 | SESE |
| K182284 | Tyber Medical PT Interbody Spacer | Tyber Medical, LLC | Jan 18, 2019 | SESE |
| K180909 | REVEL Spacers | Globus Medical, Inc. | Dec 18, 2018 | SESE |
| K181140 | Axis Chena Cervical PEEK Spacer System | Axis Orthopaedics | Nov 16, 2018 | SESE |
| K181590 | Neurostructures Cavetto® [MAX] Cervical Cage System | Neurostructures, Inc. | Nov 8, 2018 | SESE |
| K181229 | TirboLOX-C Cervical IBFD | Captiva Spine, Inc. | Sep 19, 2018 | SESE |
| K181471 | ACCUFUSE Cervical System | Absolute Advantage Medical, LLC | Aug 29, 2018 | SESE |
| K181435 | ATEC Cervical Spacer System | Alphatec Spine, Inc. | Aug 21, 2018 | SESE |
| K181115 | CxHA PEEK Cervical IBF System | Innovasis, Inc. | Jul 16, 2018 | SESE |
| K181261 | Curiteva Cervical Interbody Fusion System | Curiteva, LLC | Jul 9, 2018 | SESE |
| K180590 | Tyber Medical PT Interbody Spacer System | Tyber Medical, LLC | Jul 6, 2018 | SESE |
| K180364 | HD LifeSciences Cervical IBFD System | Hd Lifesciences, LLC | Jun 27, 2018 | SESE |
| K180674 | EVOL® ha-C Cervical Interbody Fusion System | Cutting Edge Spine, LLC | Jun 25, 2018 | SESE |
| K172788 | MONET Anterior Cervical Interbody Fusion Cage System | Ctl Medical Corporation | Jun 25, 2018 | SESE |
| K180401 | TiWAVE-C Porous Titanium Cervical Cage | Kalitec Direct, LLC | Jun 14, 2018 | SESE |
| K180675 | Atlas Spine Expandable Cervical Interbody System | Atlas Spine, Inc. | Jun 13, 2018 | SESE |
| K173722 | PATRIOT COLONIAL Spacer, SUSTAIN Spacer | Globus Medical, Inc. | May 23, 2018 | SESE |
| K173832 | InTice-C Porous Ti Cervical Interbody System | X-Spine Systems, Inc. | May 17, 2018 | SESE |
| K172480 | icotec Interbody Cage System | Icotec AG | May 17, 2018 | SESE |
| K172568 | Cervage | Precifit Medical, Ltd. | May 4, 2018 | SESE |
| K173128 | Alamo® C | Alliance Partners, LLC | Mar 22, 2018 | SESE |
| K173453 | Valeo® C+CSC with Lumen Interbody Fusion Device | Amedica Corp. | Mar 5, 2018 | SESE |
| K173324 | ALTA Anterior Cervical Interbody Spacer | Astura Medical | Feb 27, 2018 | SESE |
| K172320 | Neurostructures Cavetto® Cervical Cage System | Neurostructures, Inc. | Feb 26, 2018 | SESE |
| K173535 | Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody Fusion Device and Endoskeleton® TCS Interbody Fusion Device | Titan Spine, LLC | Feb 13, 2018 | SESE |
| K172212 | MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK | Ctl Medical Corporation | Jan 9, 2018 | SESE |
| K173159 | Cervical Spinal Truss System (CSTS) Interbody Fusion Device | 4Web, Inc. | Jan 8, 2018 | SESE |
| K173102 | Reliance Cervical IBF System | Reliance Medical Systems, LLC | Dec 29, 2017 | SESE |
| K172926 | SeaSpine Vu cPOD, Zuma-C, Complete Cervical | SeaSpine Orthopedics Corporation | Dec 21, 2017 | SESE |
| K172185 | Tyber Medical PT Interbody Spacer System | Tyber Medical, LLC | Dec 21, 2017 | SESE |
| K173115 | COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and COALITION AGX® TPS | Globus Medical, Inc. | Dec 20, 2017 | SESE |
| K172676 | NuVasive® Modulus-C Interbody System | Nu Vasive, Incorporated | Dec 14, 2017 | SESE |
| K173148 | ACIF | Coligne AG | Dec 1, 2017 | SESE |
| K173030 | Vertera Spine Cohere Cervical Interbody Fusion Device | Nu Vasive, Incorporated | Nov 21, 2017 | SESE |
| K172253 | Altus Spine Cervical Interbody Fusion System | Altus Partners, LLC | Nov 21, 2017 | SESE |
| K172446 | SPIRA-C Open Matrix Cervical Interbody | Camber Spine Technologies | Nov 7, 2017 | SESE |
| K172674 | Sapphire Cervical Implant System | Sapphire Medical Group | Nov 2, 2017 | SESE |
| K172437 | CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer System | Orthofix, Inc. | Nov 2, 2017 | SESE |
| K172065 | SCARLET AC-T | Spineart | Sep 29, 2017 | SESE |
| K172587 | Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markers | Medacta International S.A. | Sep 18, 2017 | SESE |
| K163422 | Shanghai Sanyou PEEK Cage System | Shanghai Sanyou Medical Co, Ltd. | Sep 18, 2017 | SESE |
| K172489 | Reliance Cervical IBF System | Reliance Medical Systems, LLC | Sep 7, 2017 | SESE |
| K171496 | Tritanium C Anterior Cervical Cage | Stryker Spine | Sep 6, 2017 | SESE |
| K171140 | Matrixx System | Nexxt Spine, LLC | Aug 22, 2017 | SESE |
| K171075 | Calix-C Cervical Interbody Spacer | X-Spine Systems, Inc. | Aug 1, 2017 | SESE |
| K171749 | Velofix(tm) Interbody Fusion System | U&I Corporation | Jul 13, 2017 | SESE |
| K170550 | Coveris Cervical Cage System | Camber Spine Technologies | Jul 13, 2017 | SESE |
| K170318 | NeoFuse Ti3D PLIF/TLIF/Cervical Interbody | Ht Medical, LLC | Jul 12, 2017 | SESE |
| K171046 | SeaSpine Cambria System | SeaSpine Orthopedics Corporation | Jul 7, 2017 | SESE |
| K170844 | Gemini-C Hybrid Cervical Interbody System | Osseus Fusion Systems, LLC | Jul 3, 2017 | SESE |
| K163494 | Summit Spine Channel Cervical Interbody Fusion System | Summit Spine | Jun 20, 2017 | SESE |
| K162682 | MATISSE Anterior Cervical Interbody Fusion Cage System | Ctl Medical Corporation | Jun 1, 2017 | SESE |
| K163673 | Fortilink-C with TETRAfuse 3D Technology | Rti Surgical, Inc. | May 23, 2017 | SESE |
| K162496 | Foundation 3D Interbody | Corelink, LLC | May 4, 2017 | SESE |
| K163265 | Kepler II | Orbbo Surgical, LLC | Apr 7, 2017 | SESE |
| K163491 | NuVasive CoRoent Small Interbody System | Nu Vasive, Incorporated | Mar 24, 2017 | SESE |
| K162402 | 4CIS® Marlin ACIF Cage System | Solco Biomedical Co., Ltd. | Feb 16, 2017 | SESE |
| K162587 | ROCCIA® ACIF | Silony Medical GmbH | Jan 26, 2017 | SESE |
| K170074 | nvc | Nvision Biomedical Technologies, LLC | Jan 24, 2017 | SESE |
| K162694 | Ayers Rock Cervical interbody fusion system | Spineway | Jan 12, 2017 | SESE |
| K161127 | The Small PLATEAU (PLATEAU-C) Spacer System | Life Spine, Inc. | Dec 22, 2016 | SESE |
| K162003 | IMSE Cervical Cage | The Institute of Musculoskeletal Science & Education | Dec 21, 2016 | SESE |
| K160222 | OIC Cervical PEEK Spacer | The Orthopaedic Implant Company | Dec 7, 2016 | SESE |
| K161809 | ShurFit CpTi-HA ACIF Interbody Fusion System | Precision Spine, Inc. | Dec 6, 2016 | SESE |
| K162220 | DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) Cage | Dio Medical Co., Ltd. | Nov 21, 2016 | SESE |
| K161649 | Virtu C Spinal Implant System | Met 1 Technologies, LLC | Nov 9, 2016 | SESE |
| K162138 | NuVasive CoRoent Small Ti-C System | Nu Vasive, Incorporated | Oct 26, 2016 | SESE |
| K161642 | CAVUX Cervical Cage | Providence Medical Technology, Inc. | Oct 7, 2016 | SESE |
| K161608 | InterForm Cervical Interbody Cage System | Next Orthosurgical | Sep 30, 2016 | SESE |
| K161407 | Ascential IBD PEEKc Spacer | Stryker Spine | Jul 15, 2016 | SESE |
Top Applicants
- Orthofix, Inc. — 9 clearances
- Nu Vasive, Incorporated — 8 clearances
- Medtronic Sofamor Danek USA, Inc. — 7 clearances
- Globus Medical, Inc. — 7 clearances
- Gbs Commonwealth Co., Ltd. — 7 clearances
