OVE

Intervertebral Fusion Device With Integrated Fixation, Cervical

Product code
OVE
Device name
Intervertebral Fusion Device With Integrated Fixation, Cervical
Device class
Class 2
21 CFR
21 CFR 888.3080
Medical specialty
Orthopedic
Marketing pathway
510(K)
Flag
Implant
510(k) clearances (last 3 years)
33
Summaries archived here
28 (direct download)
510(k) clearances (all years, FDA)
166 (all years; only the last 3 years are listed here)

FDA classification definition

Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (33)

Last three years. Most recent: 2026-08-21.

NumberDecision dateApplicantDevice nameSummary
K2618822026-08-21Osseus Fusions Systems, LLCPisces-SC Standalone Cervical Interbody SystemFDA
K2614512026-07-31ZSFab, Inc.ZSAlign Cervical Interbody SystemPDF
K2620942026-07-22Evolution SpineE3D™-C Interbody SystemPDF
K2612792026-06-22Nexus SpineDeltaNEC Interbody SystemPDF
K2529822026-06-18Avalign Technologies, Inc.CONDUIT™ ZERO-P™ VA Secured Spacer SystemFDA
K2600362026-06-15Medyssey Co, Ltd.NeckTune™ 3D SA Cervical CagePDF
K2606602026-04-27Elevation SpineSABER-C SystemPDF
K2532132026-04-20ZheJiang Decans Medical Devices Co., L…SAGI Cervical Cage SystemPDF
K2527742026-04-15ZheJiang Decans Medical Devices Co., L…Uni-C Cervical Cage SystemPDF
K2600382026-02-04Evolution SpineE3D™-C Interbody SystemPDF
K2538762025-12-22Globus Medical, Inc.HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)PDF
K2532002025-12-114Web Medical, Inc.Cervical Spine Truss System - Stand Alone (CSTS-SA)FDA
K2500762025-09-25InnovasisEndeavor™ Stand-Alone Cervical IBF SystemPDF
K2505402025-08-08Elevation SpineSABER-C SystemPDF
K2517352025-07-30Acuity Surgical Devices, LLCStabilis SA Cervical Stand-Alone System (Various PNs…PDF
K2514312025-06-27Jeil Medical CorporationFIX-C PEEK ACIF SA SystemPDF
K2511172025-04-254Web MedicalCervical Spine Truss System (CSTS)FDA
K2429282025-04-10Kyocera Medical Technologies, Inc.Tesera-k SC SystemPDF
K2431882025-02-11Signus Medizintechnik GmbHCYLOX® STPDF
K2424832025-02-07Genesys SpineGenesys Spine AIS-C II Cervical Interbody Fusion Sys…PDF
K2425172024-11-20Pro Surgical, Inc.ProAM ACDF SystemPDF
K2418462024-08-12Evolution SpineE3D™-C Interbody SystemPDF
K2414672024-07-17Nexus Spine, LLCStable-C Interbody SystemPDF
K2406992024-05-10Spineart SASCARLET® AC-TiPDF
K2341192024-04-19Innosys Co., Ltd.UniSpace® Stand-Alone C CagePDF
K2407152024-03-22ClarianceIdys® C ZP 3DTiPDF
K2335942023-12-13Genesys SpineGenesys Spine 3DP AIS-C II Cervical Interbody SystemPDF
K2334142023-11-28SeaSpine Orthopedics CorporationShoreline ACS Interbody System; Shoreline RT Interbo…PDF
K2331912023-11-21Spinal Analytics & Geometrical Implant…TotalTi ACDF by SAGICOFDA
K2323482023-10-27MiRus, LLCRIGEL™ 3DR Standalone Anterior Cervical Interbody Fu…PDF
K2317042023-10-19Life Spine, Inc.Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer Syste…PDF
K2317392023-09-254Web Medical, Inc.Cervical Spine Truss System (CSTS)PDF
K2238692023-09-14Choice Spine, LLCChoiceSpine Blackhawk Ti Cervical Spacer SystemPDF

28 summaries are archived here for direct download.

Official FDA classification page: OVE
Classification and pathway per current FDA publications. Data from openFDA (CC0).