FDA Product Code
FDA Product Code ODP — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3080
510(k) Clearances — 354 records · page 2 of 4
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K202872 | Prase PEEK Anterior Cervical Interbody Spacer | Gbs Commonwealth Co., Ltd. | 2021-02-04 | Traditional | PDF ↗ |
| K200429 | BEE Cages | NGMedical GmbH | 2021-01-29 | Traditional | PDF ↗ |
| K202398 | Ti3Z Cervical Interbody System | Zavation Medical Products, LLC | 2021-01-29 | Traditional | PDF ↗ |
| K202488 | ZSFab Cervical Interbody System | Zsfab, Inc. | 2021-01-07 | Traditional | PDF ↗ |
| K200458 | Tailored-C Cervical Interbody Fusion System | Bespoke Technologies | 2020-12-28 | Traditional | PDF ↗ |
| K201643 | ChoiceSpine Tiger Shark Cervical Spacer System | Choice Spine, LLC | 2020-12-22 | Traditional | PDF ↗ |
| K200549 | Lucero Medical Cervical Cage System | Lucero Medical, LLC | 2020-12-16 | Traditional | PDF ↗ |
| K202302 | Atlas Spine Rebar (Ti) Spacer System | Atlas Spine, Inc. | 2020-10-30 | Traditional | PDF ↗ |
| K202949 | CONSTRUX Mini PEEK Spacer System | Orthofix, Inc. | 2020-10-29 | Special | PDF ↗ |
| K202666 | CONSTRUX Mini PTC Spacer System | Orthofix, Inc. | 2020-10-14 | Special | PDF ↗ |
| K201506 | Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical Intervertebral Body Fusion System | Meditech Spine, LLC | 2020-09-11 | Special | PDF ↗ |
| K201769 | Cavetto [MAX] Cervical Cage System | Neurostructures, Inc. | 2020-09-03 | Traditional | PDF ↗ |
| K200592 | GS Medical AnyPlus PEEK Cage System | GS Medical Co., Ltd. | 2020-08-10 | Traditional | PDF ↗ |
| K200685 | RIGEL 3DR Anterior Cervical Interbody Fusion System | MiRus, LLC | 2020-06-11 | Traditional | PDF ↗ |
| K200052 | CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer System | Orthofix, Inc. | 2020-04-09 | Traditional | PDF ↗ |
| K200312 | Tryptik Ti | Spineart | 2020-04-06 | Traditional | PDF ↗ |
| K192897 | icotec Cervical Cage | Icotec AG | 2020-03-20 | Traditional | PDF ↗ |
| K193359 | SureMAX Family of Cervical Spacers | Additive Implants, Inc. | 2020-01-03 | Special | PDF ↗ |
| K192044 | 4CIS Marlin PEEK ACIF Cage | Solco Biomedical Co., Ltd. | 2019-12-19 | Traditional | PDF ↗ |
| K191812 | ADI Cervical Interbody Fusion Device | Additive Device, Inc. (Adi) D/B/A Restor3D | 2019-10-24 | Traditional | PDF ↗ |
| K192316 | Matrix HA PEEK Cervical Implant System | Sapphire Medical Group | 2019-10-17 | Special | PDF ↗ |
| K191822 | Nano FortiCore, FortiCore | Nanovis, LLC | 2019-10-11 | Traditional | PDF ↗ |
| K192208 | CORNICE Cervical Spacer System | Legend Spine Technologies | 2019-10-09 | Traditional | PDF ↗ |
| K191537 | eCarbon IBDs | Back 2 Basics Direct, LLC | 2019-09-26 | Traditional | PDF ↗ |
| K191243 | HEDRON Cervical Spacers | Globus Medical, Inc. | 2019-09-17 | Traditional | PDF ↗ |
| K191354 | Ti3Z Cervical Interbody System | Zavation Medical Products, LLC | 2019-09-09 | Traditional | PDF ↗ |
| 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. | 2019-08-16 | Special | PDF ↗ |
| 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 | 2019-08-15 | Special | PDF ↗ |
| K190291 | Addivation Medical Cervical Interbody System | Addivation Medical, LLC | 2019-07-30 | Traditional | PDF ↗ |
| K190889 | Republic Spine Restore Cervical Interbody Fusion System | Republic Spine, LLC | 2019-06-19 | Traditional | PDF ↗ |
| K182608 | Oyster ACIF Cage | Silony Medical GmbH | 2019-06-13 | Traditional | PDF ↗ |
| K190618 | RIGEL PEEK Anterior Cervical Interbody Fusion System | MiRus, LLC | 2019-06-06 | Traditional | PDF ↗ |
| K190380 | nvc | Nvision Biomedical Technologies, Inc. | 2019-03-21 | Special | PDF ↗ |
| K183397 | ChoiceSpine Stealth Cervical Spacer System | Choicespine, LP | 2019-03-06 | Special | PDF ↗ |
| K190322 | SCARLET® AC-T Secured Anterior Cervical Cage | Spineart | 2019-03-04 | Special | PDF ↗ |
| K183083 | Shoreline Cervical Interbody RT System | SeaSpine Orthopedics Corporation | 2019-02-14 | Traditional | PDF ↗ |
| 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. | 2019-02-11 | Special | PDF ↗ |
| K190067 | Velofix Interbody Fusion System | U&I Corporation | 2019-02-04 | Special | PDF ↗ |
| K182477 | Cervical Spacer | Additive Implants, LLC | 2019-01-28 | Traditional | PDF ↗ |
| K182284 | Tyber Medical PT Interbody Spacer | Tyber Medical, LLC | 2019-01-18 | Traditional | PDF ↗ |
| K180909 | REVEL Spacers | Globus Medical, Inc. | 2018-12-18 | Traditional | PDF ↗ |
| K181140 | Axis Chena Cervical PEEK Spacer System | Axis Orthopaedics | 2018-11-16 | Traditional | PDF ↗ |
| K181590 | Neurostructures Cavetto® [MAX] Cervical Cage System | Neurostructures, Inc. | 2018-11-08 | Special | PDF ↗ |
| K181229 | TirboLOX-C Cervical IBFD | Captiva Spine, Inc. | 2018-09-19 | Traditional | PDF ↗ |
| K181471 | ACCUFUSE Cervical System | Absolute Advantage Medical, LLC | 2018-08-29 | Traditional | PDF ↗ |
| K181435 | ATEC Cervical Spacer System | Alphatec Spine, Inc. | 2018-08-21 | Traditional | PDF ↗ |
| K181115 | CxHA PEEK Cervical IBF System | Innovasis, Inc. | 2018-07-16 | Traditional | PDF ↗ |
| K181261 | Curiteva Cervical Interbody Fusion System | Curiteva, LLC | 2018-07-09 | Traditional | PDF ↗ |
| K180590 | Tyber Medical PT Interbody Spacer System | Tyber Medical, LLC | 2018-07-06 | Traditional | PDF ↗ |
| K180364 | HD LifeSciences Cervical IBFD System | Hd Lifesciences, LLC | 2018-06-27 | Traditional | PDF ↗ |
| K172788 | MONET Anterior Cervical Interbody Fusion Cage System | Ctl Medical Corporation | 2018-06-25 | Traditional | PDF ↗ |
| K180674 | EVOL® ha-C Cervical Interbody Fusion System | Cutting Edge Spine, LLC | 2018-06-25 | Traditional | PDF ↗ |
| K180401 | TiWAVE-C Porous Titanium Cervical Cage | Kalitec Direct, LLC | 2018-06-14 | Traditional | PDF ↗ |
| K180675 | Atlas Spine Expandable Cervical Interbody System | Atlas Spine, Inc. | 2018-06-13 | Traditional | PDF ↗ |
| K173722 | PATRIOT COLONIAL Spacer, SUSTAIN Spacer | Globus Medical, Inc. | 2018-05-23 | Traditional | PDF ↗ |
| K172480 | icotec Interbody Cage System | Icotec AG | 2018-05-17 | Traditional | PDF ↗ |
| K173832 | InTice-C Porous Ti Cervical Interbody System | X-Spine Systems, Inc. | 2018-05-17 | Traditional | PDF ↗ |
| K172568 | Cervage | Precifit Medical, Ltd. | 2018-05-04 | Traditional | PDF ↗ |
| K173128 | Alamo® C | Alliance Partners, LLC | 2018-03-22 | Traditional | PDF ↗ |
| K173453 | Valeo® C+CSC with Lumen Interbody Fusion Device | Amedica Corp. | 2018-03-05 | Traditional | PDF ↗ |
| K173324 | ALTA Anterior Cervical Interbody Spacer | Astura Medical | 2018-02-27 | Traditional | PDF ↗ |
| K172320 | Neurostructures Cavetto® Cervical Cage System | Neurostructures, Inc. | 2018-02-26 | Traditional | PDF ↗ |
| K173535 | Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody Fusion Device and Endoskeleton® TCS Interbody Fusion Device | Titan Spine, LLC | 2018-02-13 | Special | PDF ↗ |
| K172212 | MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK | Ctl Medical Corporation | 2018-01-09 | Traditional | PDF ↗ |
| K173159 | Cervical Spinal Truss System (CSTS) Interbody Fusion Device | 4Web, Inc. | 2018-01-08 | Traditional | PDF ↗ |
| K173102 | Reliance Cervical IBF System | Reliance Medical Systems, LLC | 2017-12-29 | Special | PDF ↗ |
| K172185 | Tyber Medical PT Interbody Spacer System | Tyber Medical, LLC | 2017-12-21 | Traditional | PDF ↗ |
| K172926 | SeaSpine Vu cPOD, Zuma-C, Complete Cervical | SeaSpine Orthopedics Corporation | 2017-12-21 | Traditional | PDF ↗ |
| K173115 | COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and COALITION AGX® TPS | Globus Medical, Inc. | 2017-12-20 | Traditional | PDF ↗ |
| K172676 | NuVasive® Modulus-C Interbody System | Nu Vasive, Incorporated | 2017-12-14 | Traditional | PDF ↗ |
| K173148 | ACIF | Coligne AG | 2017-12-01 | Traditional | PDF ↗ |
| K172253 | Altus Spine Cervical Interbody Fusion System | Altus Partners, LLC | 2017-11-21 | Traditional | PDF ↗ |
| K173030 | Vertera Spine Cohere Cervical Interbody Fusion Device | Nu Vasive, Incorporated | 2017-11-21 | Traditional | PDF ↗ |
| K172446 | SPIRA-C Open Matrix Cervical Interbody | Camber Spine Technologies | 2017-11-07 | Traditional | PDF ↗ |
| K172674 | Sapphire Cervical Implant System | Sapphire Medical Group | 2017-11-02 | Special | PDF ↗ |
| K172437 | CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer System | Orthofix, Inc. | 2017-11-02 | Special | PDF ↗ |
| K172065 | SCARLET AC-T | Spineart | 2017-09-29 | Traditional | PDF ↗ |
| K163422 | Shanghai Sanyou PEEK Cage System | Shanghai Sanyou Medical Co, Ltd. | 2017-09-18 | Traditional | PDF ↗ |
| K172587 | Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markers | Medacta International S.A. | 2017-09-18 | Special | PDF ↗ |
| K172489 | Reliance Cervical IBF System | Reliance Medical Systems, LLC | 2017-09-07 | Special | PDF ↗ |
| K171496 | Tritanium C Anterior Cervical Cage | Stryker Spine | 2017-09-06 | Traditional | PDF ↗ |
| K171140 | Matrixx System | Nexxt Spine, LLC | 2017-08-22 | Traditional | PDF ↗ |
| K171075 | Calix-C Cervical Interbody Spacer | X-Spine Systems, Inc. | 2017-08-01 | Traditional | PDF ↗ |
| K170550 | Coveris Cervical Cage System | Camber Spine Technologies | 2017-07-13 | Traditional | PDF ↗ |
| K171749 | Velofix(tm) Interbody Fusion System | U&I Corporation | 2017-07-13 | Traditional | PDF ↗ |
| K170318 | NeoFuse Ti3D PLIF/TLIF/Cervical Interbody | Ht Medical, LLC | 2017-07-12 | Traditional | PDF ↗ |
| K171046 | SeaSpine Cambria System | SeaSpine Orthopedics Corporation | 2017-07-07 | Traditional | PDF ↗ |
| K170844 | Gemini-C Hybrid Cervical Interbody System | Osseus Fusion Systems, LLC | 2017-07-03 | Traditional | PDF ↗ |
| K163494 | Summit Spine Channel Cervical Interbody Fusion System | Summit Spine | 2017-06-20 | Traditional | PDF ↗ |
| K162682 | MATISSE Anterior Cervical Interbody Fusion Cage System | Ctl Medical Corporation | 2017-06-01 | Traditional | PDF ↗ |
| K163673 | Fortilink-C with TETRAfuse 3D Technology | Rti Surgical, Inc. | 2017-05-23 | Traditional | PDF ↗ |
| K162496 | Foundation 3D Interbody | Corelink, LLC | 2017-05-04 | Traditional | PDF ↗ |
| K163265 | Kepler II | Orbbo Surgical, LLC | 2017-04-07 | Traditional | PDF ↗ |
| K163491 | NuVasive CoRoent Small Interbody System | Nu Vasive, Incorporated | 2017-03-24 | Traditional | PDF ↗ |
| K162402 | 4CIS® Marlin ACIF Cage System | Solco Biomedical Co., Ltd. | 2017-02-16 | Traditional | PDF ↗ |
| K162587 | ROCCIA® ACIF | Silony Medical GmbH | 2017-01-26 | Traditional | PDF ↗ |
| K170074 | nvc | Nvision Biomedical Technologies, LLC | 2017-01-24 | Special | PDF ↗ |
| K162694 | Ayers Rock Cervical interbody fusion system | Spineway | 2017-01-12 | Traditional | PDF ↗ |
| K161127 | The Small PLATEAU (PLATEAU-C) Spacer System | Life Spine, Inc. | 2016-12-22 | Traditional | PDF ↗ |
| K162003 | IMSE Cervical Cage | The Institute of Musculoskeletal Science & Education | 2016-12-21 | Traditional | PDF ↗ |
Product code ODP · Class II · Orthopedic. Data: openFDA.