ClearanceBrief
Panels › Orthopedic › Product code OVE · Class 2

Intervertebral Fusion Device With Integrated Fixation, Cervical

Regulation 888.3080

15510(k)s in 12 months (169 all time)
0recalls in 12 months (12 all time)
12recalls that name a 510(k)
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Top companies in OVE

Company510(k)sRecalls
SeaSpine Orthopedics Corporation80
Genesys Spine60
Titan Spine, Inc.42
Medtronic Sofamor Danek41
Synthes Spine50
4Web Medical40
Centinel Spine, Inc.40
Elevation Spine40
Globus Medical, Inc.40
Life Spine, Inc.40
Decided510(k)Device and applicantCode
Oct 2, 2026K263113ZSAlign Cervical Interbody System
ZSFab, Inc.
OVE
Sep 29, 2026K262726NeckTune™ SA Cervical Cage
Medyssey Co., Ltd., KR
OVE
Sep 23, 2026K263049SABER-C System
Elevation Spine
OVE
Aug 21, 2026K261882Pisces-SC Standalone Cervical Interbody System
Osseus Fusions Systems, LLC
OVE
Jul 31, 2026K261451ZSAlign Cervical Interbody System
ZSFab, Inc.
OVE
Jul 22, 2026K262094E3D™-C Interbody System
Evolution Spine
OVE
Jun 22, 2026K261279DeltaNEC Interbody System
Nexus Spine
OVE
Jun 18, 2026K252982CONDUIT™ ZERO-P™ VA Secured Spacer System
Avalign Technologies, Inc.
OVE
Jun 15, 2026K260036NeckTune™ 3D SA Cervical Cage
Medyssey Co, Ltd., KR
OVE
Apr 27, 2026K260660SABER-C System
Elevation Spine
OVE
Apr 20, 2026K253213SAGI Cervical Cage System
ZheJiang Decans Medical Devices Co., Ltd., CN
OVE
Apr 15, 2026K252774Uni-C Cervical Cage System
ZheJiang Decans Medical Devices Co., Ltd., CN
OVE
Feb 4, 2026K260038E3D™-C Interbody System
Evolution Spine
OVE
Dec 22, 2025K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)
Globus Medical, Inc.
OVE
Dec 11, 2025K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)
4Web Medical, Inc.
OVE
Sep 25, 2025K250076Endeavor™ Stand-Alone Cervical IBF System
Innovasis
OVE
Aug 8, 2025K250540SABER-C System
Elevation Spine
OVE
Jul 30, 2025K251735Stabilis SA Cervical Stand-Alone System (Various PNs)
Acuity Surgical Devices, LLC
OVE
Jun 27, 2025K251431FIX-C PEEK ACIF SA System
Jeil Medical Corporation, KR
OVE
Apr 25, 2025K251117Cervical Spine Truss System (CSTS)
4Web Medical
OVE
Apr 10, 2025K242928Tesera-k SC System
Kyocera Medical Technologies, Inc.
OVE
Feb 11, 2025K243188CYLOX® ST
Signus Medizintechnik GmbH, DE
OVE
Feb 7, 2025K242483Genesys Spine AIS-C II Cervical Interbody Fusion System
Genesys Spine
OVE
Nov 20, 2024K242517ProAM ACDF System
Pro Surgical, Inc.
OVE
Aug 12, 2024K241846E3D™-C Interbody System
Evolution Spine
OVE
Jul 17, 2024K241467Stable-C Interbody System
Nexus Spine, LLC
OVE
May 10, 2024K240699SCARLET® AC-Ti
Spineart SA, CH
OVE
Apr 19, 2024K234119UniSpace® Stand-Alone C Cage
Innosys Co., Ltd., KR
OVE
Mar 22, 2024K240715Idys® C ZP 3DTi
Clariance, FR
OVE
Dec 13, 2023K233594Genesys Spine 3DP AIS-C II Cervical Interbody System
Genesys Spine
OVE
Nov 28, 2023K233414Shoreline ACS Interbody System; Shoreline RT Interbody System
SeaSpine Orthopedics Corporation
OVE
Nov 21, 2023K233191TotalTi ACDF by SAGICO
Spinal Analytics & Geometrical Implant Co, LLC
OVE
Oct 27, 2023K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System
MiRus, LLC
OVE
Oct 19, 2023K231704Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer System
Life Spine, Inc.
OVE
Sep 25, 2023K231739Cervical Spine Truss System (CSTS)
4Web Medical, Inc.
OVE
Sep 14, 2023K223869ChoiceSpine Blackhawk Ti Cervical Spacer System
Choice Spine, LLC
OVE
Aug 21, 2023K231763Stable-C Interbody System
Nexus Spine, LLC
OVE
Aug 14, 2023K230608SPICCA Stand-Alone Cervical Fusion Cages
Southern Medical (Pty) , Ltd., ZA
OVE
Aug 4, 2023K221138Titus Titanium Cervical by SAGICO
Sagico VA USA, LLC
OVE
Jul 20, 2023K231808QUASAR Standalone ACIF System
GS Medical Co., Ltd., KR
OVE
Jun 26, 2023K223143SAGICO Spinal System
Sagico VA USA, LLC
OVE
Jun 7, 2023K223059Xenco Medical InterAlign Cervical Interbody System
Xenco Medical, LLC
OVE
Mar 22, 2023K223837SPIRA®-C Integrated Fixation System
Camber Spine Technologies
OVE
Feb 9, 2023K222041CYGNUS-C Standalone ACIF System
GS Medical Co., Ltd., KR
OVE
Feb 2, 2023K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device
4Web Medical, Inc.
OVE
Dec 22, 2022K223105Tesera-K SC System
Kyocera Medical Technologies, Inc.
OVE
Dec 20, 2022K223140AEON-C™ Stand Alone System
Dio Medical, Inc.
OVE
Dec 12, 2022K223190Hive™ Standalone Cervical System
NanoHive Medical, LLC
OVE
Nov 18, 2022K222903Tailored-H Cervical Stand Alone System
Bespoke Technologies, LLC
OVE
Nov 15, 2022K212612Omnia Medical TiBrid-SC
Omnia Medical, LLC
OVE

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