Atlas FDA

OVE

165 FDA 510(k) clearances · Product code

119 daysmedian time to decision
250 days90th percentile
165clearances measured

FDA profile

Official device name
Intervertebral Fusion Device With Integrated Fixation, Cervical
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3080
Medical specialty
Orthopedic
Flags
Implant
FDA 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.
Adverse events (MAUDE)
2021: 186 · 2022: 200 · 2023: 148 · 2024: 142 · 2025: 136 · 2026: 89
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
ZSAlign Cervical Interbody System (K261451)ZSFab, Inc.2026-07-31
E3D™-C Interbody System (K262094)Evolution Spine2026-07-22
DeltaNEC Interbody System (K261279)Nexus Spine2026-06-22
CONDUIT™ ZERO-P™ VA Secured Spacer System (K252982)Avalign Technologies, Inc.2026-06-18
NeckTune™ 3D SA Cervical Cage (K260036)Medyssey Co, Ltd.2026-06-15
SABER-C System (K260660)Elevation Spine2026-04-27
SAGI Cervical Cage System (K253213)ZheJiang Decans Medical Devices Co., Ltd.2026-04-20
Uni-C Cervical Cage System (K252774)ZheJiang Decans Medical Devices Co., Ltd.2026-04-15
E3D™-C Interbody System (K260038)Evolution Spine2026-02-04
HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer) (K253876)Globus Medical, Inc.2025-12-22
Cervical Spine Truss System - Stand Alone (CSTS-SA) (K253200)4Web Medical, Inc.2025-12-11
Endeavor™ Stand-Alone Cervical IBF System (K250076)Innovasis2025-09-25
SABER-C System (K250540)Elevation Spine2025-08-08
Stabilis SA Cervical Stand-Alone System (Various PNs) (K251735)Acuity Surgical Devices, LLC2025-07-30
FIX-C PEEK ACIF SA System (K251431)Jeil Medical Corporation2025-06-27
Cervical Spine Truss System (CSTS) (K251117)4Web Medical2025-04-25
Tesera-k SC System (K242928)Kyocera Medical Technologies, Inc.2025-04-10
CYLOX® ST (K243188)Signus Medizintechnik GmbH2025-02-11
Genesys Spine AIS-C II Cervical Interbody Fusion System (K242483)Genesys Spine2025-02-07
ProAM ACDF System (K242517)Pro Surgical, Inc.2024-11-20
E3D™-C Interbody System (K241846)Evolution Spine2024-08-12
Stable-C Interbody System (K241467)Nexus Spine, LLC2024-07-17
SCARLET® AC-Ti (K240699)Spineart SA2024-05-10
UniSpace® Stand-Alone C Cage (K234119)Innosys Co., Ltd.2024-04-19
Idys® C ZP 3DTi (K240715)Clariance2024-03-22
Genesys Spine 3DP AIS-C II Cervical Interbody System (K233594)Genesys Spine2023-12-13
Shoreline ACS Interbody System; Shoreline RT Interbody System (K233414)SeaSpine Orthopedics Corporation2023-11-28
TotalTi ACDF by SAGICO (K233191)Spinal Analytics & Geometrical Implant Co, LLC2023-11-21
RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System (K232348)MiRus, LLC2023-10-27
Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer System (K231704)Life Spine, Inc.2023-10-19
Cervical Spine Truss System (CSTS) (K231739)4Web Medical, Inc.2023-09-25
ChoiceSpine Blackhawk Ti Cervical Spacer System (K223869)Choice Spine, LLC2023-09-14
Stable-C Interbody System (K231763)Nexus Spine, LLC2023-08-21
SPICCA Stand-Alone Cervical Fusion Cages (K230608)Southern Medical (Pty) , Ltd.2023-08-14
Titus Titanium Cervical by SAGICO (K221138)Sagico VA USA, LLC2023-08-04
QUASAR Standalone ACIF System (K231808)GS Medical Co., Ltd.2023-07-20
SAGICO Spinal System (K223143)Sagico VA USA, LLC2023-06-26
Xenco Medical InterAlign Cervical Interbody System (K223059)Xenco Medical, LLC2023-06-07
SPIRA®-C Integrated Fixation System (K223837)Camber Spine Technologies2023-03-22
CYGNUS-C Standalone ACIF System (K222041)GS Medical Co., Ltd.2023-02-09
Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device (K223362)4Web Medical, Inc.2023-02-02
Tesera-K SC System (K223105)Kyocera Medical Technologies, Inc.2022-12-22
AEON-C™ Stand Alone System (K223140)Dio Medical, Inc.2022-12-20
Hive™ Standalone Cervical System (K223190)NanoHive Medical, LLC2022-12-12
Tailored-H Cervical Stand Alone System (K222903)Bespoke Technologies, LLC2022-11-18
Omnia Medical TiBrid-SC (K212612)Omnia Medical, LLC2022-11-15
Hexanium ACIF (K221578)Spinevision, S.A.S.2022-11-14
Zavation VariSync Plate System and VariSync Spacer System (K221049)Zavation Medical Products, LLC2022-08-12
Unispace SA Cervical Cage (K213791)Edisoninno Co., Ltd.2022-08-05
F3D-C2 Cervical Stand-Alone System (K211417)Corelink, LLC2022-02-04
Romero Cervical Cage (K212358)Spineup, Inc.2022-01-10
SeaSpine WaveForm C Interbody System (K212904)SeaSpine Orthopedics Corporation2021-12-14
SeaSpine WaveForm, C Interbody System (K213359)SeaSpine Orthopedics Corporation2021-12-09
Velofix SA Cervical Cage (K210573)U&I Corporation2021-11-19
Cervical Stand-Alone System (K212853)Eminent Spine, LLC2021-11-05
Idys-C ZP 3DTi (K212562)Clariance, SA2021-10-12
C-CURVE Interbody Fusion Device (K210470)Medicrea International SA2021-09-03
Blustone Synergy Diamond SA Cervical System (K210382)Blustone Synergy, LLC2021-07-23
SureMAX-SA Cervical Standalone System (K211111)Additive Implants, Inc.2021-07-16
ChoiceSpine Blackhawk Ti Cervical Spacer System (K203311)Choice Spine, LLC2021-05-10
NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System (K203129)Precision Spine, Inc.2021-01-12
IdentiTi Cervical Standalone Interbody System (K202812)Alphatec Spine, Inc.2020-12-18
Mecta-C Stand Alone Extension (K203076)Medacta International S.A.2020-11-06
DOLOMITE Anterior Cervical Stabilization System (K202065)Astura Medical, LLC2020-10-26
Hexanium® ACIF (K193000)Spinevision, S.A.S.2020-10-20
Cavetto-SA Cervical Cage System (K200115)Neurostructures, Inc.2020-09-24
Seaspine WaveForm C Interbody System (K201073)SeaSpine Orthopedics Corporation2020-09-18
Shoreline ACS (Anterior Cervical System) (K201646)SeaSpine Orthopedics Corporation2020-09-14
F3D Cervical Stand-Alone Interbody Fusion System (K200087)Corelink, LLC2020-06-15
SPIRA-C Integrated Fixation System (K193153)Camber Spine Technologies2020-04-24
NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) System (K200543)Nexxt Spine, LLC2020-03-23
Mecta-C Stand Alone (K192906)Medacta International S.A.2020-03-04
Atlas Spine Expandable Cervical Standalone Interbody System (K192570)Atlas Spine, Inc.2020-02-28
Genesys Spine 3DP Cervical Interbody System (K191489)Genesys Spine2020-01-08
NuVasive CoRoent Small Interlock System (K192582)Nu Vasive, Incorporated2019-11-13
AEON-C Stand Alone System (K191477)Huvexel Co. , Ltd.2019-11-13
Cervical Spinal Truss System-Stand Alone (CSTS-SA) (K190870)4Web, Inc.2019-08-12
Elevation Spine Saber-C System (K190885)Elevation Spine2019-08-07
Endoskeleton TCS Interbody Fusion Device (K191565)Titan Spine, Inc.2019-08-06
NEXXT MATRIXX Stand Alone Cervical System (K190546)Nexxt Spine, LLC2019-05-31
SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone System (K190655)SeaSpine Orthopedics Corporation2019-04-29
Stable-C Interbody System (K181621)Nexus Spine, LLC2018-10-19
MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate (K182151)Ctl Medical Corporation2018-10-11
Genesys Spine AIS-C Cervical Stand-Alone System (K181295)Genesys Spine2018-08-29
Pro-Link® Ti Stand-Alone Cervical Spacer System (K180642)Life Spine, Inc.2018-05-10
A-CIFT SoloFuse (K172484)Spinefrontier, Inc.2018-05-08
Genesys Spine AIS-C Cervical Anchored Interbody System (K180056)Genesys Spine2018-03-28
Cavetto-SA Cervical Cage System (K173077)Neurostructures, Inc.2018-02-23
Velofix™ SA Cervical Cage (K172424)U&I Corporation2017-11-22
Paramount Anterior Cervical Cage System (K173175)Spine Wave, Inc.2017-11-01
Acapella Cervical Spacer System (K171489)Choicespine, LP2017-10-23
Unison-C Anterior Cervical Fixation System (K170830)Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.2017-06-28
SeaSpine Shoreline ACS - Anterior Cervical Standalone System (K170569)SeaSpine Orthopedics Corporation2017-06-15
NuVasive CoRoent Small Interlock II System (K170961)Nu Vasive, Incorporated2017-06-08
Tomcat Cervical Spinal System (K170953)Choicespine, LP2017-04-21
CAVUX CervicalCage-L SA System (K163474)Providence Medical Technology, Inc.2017-03-10
Spine Wave Anterior Cervical Spine System (K162760)Spine Wave, Inc.2017-02-16
STERISPINE CC (K162531)Safe Orthopaedics2016-12-29
Irix-C Cervical Integrated Fusion System (K162944)X-Spine Systems, Inc.2016-11-07
Xenco Medical Cervical Interbody System (K160313)Xenco Medical, LLC2016-10-21
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