Product code OVE
- Device name
- Intervertebral Fusion Device With Integrated Fixation, Cervical
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3080
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- 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.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260660 | SABER-C System | Elevation Spine | 2026-04-27 |
| K253213 | SAGI Cervical Cage System | ZheJiang Decans Medical Devices Co., Ltd. | 2026-04-20 |
| K252774 | Uni-C Cervical Cage System | ZheJiang Decans Medical Devices Co., Ltd. | 2026-04-15 |
| K260038 | E3D™-C Interbody System | Evolution Spine | 2026-02-04 |
| K253876 | HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer) | Globus Medical, Inc. | 2025-12-22 |
| K253200 | Cervical Spine Truss System - Stand Alone (CSTS-SA) | 4Web Medical, Inc. | 2025-12-11 |
| K250076 | Endeavor™ Stand-Alone Cervical IBF System | Innovasis | 2025-09-25 |
| K250540 | SABER-C System | Elevation Spine | 2025-08-08 |
| K251735 | Stabilis SA Cervical Stand-Alone System (Various PNs) | Acuity Surgical Devices, LLC | 2025-07-30 |
| K251431 | FIX-C PEEK ACIF SA System | Jeil Medical Corporation | 2025-06-27 |
| K251117 | Cervical Spine Truss System (CSTS) | 4Web Medical | 2025-04-25 |
| K242928 | Tesera-k SC System | Kyocera Medical Technologies, Inc. | 2025-04-10 |
| K243188 | CYLOX® ST | Signus Medizintechnik GmbH | 2025-02-11 |
| K242483 | Genesys Spine AIS-C II Cervical Interbody Fusion System | Genesys Spine | 2025-02-07 |
| K242517 | ProAM ACDF System | Pro Surgical, Inc. | 2024-11-20 |
| K241846 | E3D™-C Interbody System | Evolution Spine | 2024-08-12 |
| K241467 | Stable-C Interbody System | Nexus Spine, LLC | 2024-07-17 |
| K240699 | SCARLET® AC-Ti | Spineart SA | 2024-05-10 |
| K234119 | UniSpace® Stand-Alone C Cage | Innosys Co., Ltd. | 2024-04-19 |
| K240715 | Idys® C ZP 3DTi | Clariance | 2024-03-22 |
| K233594 | Genesys Spine 3DP AIS-C II Cervical Interbody System | Genesys Spine | 2023-12-13 |
| K233414 | Shoreline ACS Interbody System; Shoreline RT Interbody System | SeaSpine Orthopedics Corporation | 2023-11-28 |
| K233191 | TotalTi ACDF by SAGICO | Spinal Analytics & Geometrical Implant Co, LLC | 2023-11-21 |
| K232348 | RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System | MiRus, LLC | 2023-10-27 |
| K231704 | Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer System | Life Spine, Inc. | 2023-10-19 |
| K231739 | Cervical Spine Truss System (CSTS) | 4Web Medical, Inc. | 2023-09-25 |
| K223869 | ChoiceSpine Blackhawk Ti Cervical Spacer System | Choice Spine, LLC | 2023-09-14 |
| K231763 | Stable-C Interbody System | Nexus Spine, LLC | 2023-08-21 |
| K230608 | SPICCA Stand-Alone Cervical Fusion Cages | Southern Medical (Pty) , Ltd. | 2023-08-14 |
| K221138 | Titus Titanium Cervical by SAGICO | Sagico VA USA, LLC | 2023-08-04 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07640221370419 | SCARLET® AC-Ti | SpineArt SA | 2025-11-10 |
| 07640221370464 | SCARLET® AC-Ti | SpineArt SA | 2025-11-10 |
| 07640221370471 | SCARLET® AC-Ti | SpineArt SA | 2025-11-10 |
| 07640332478127 | SCARLET® AC-Ti | SpineArt SA | 2024-08-06 |
| 07640332478042 | SCARLET® AC-Ti | SpineArt SA | 2024-08-06 |
| 07640332478059 | SCARLET® AC-Ti | SpineArt SA | 2024-08-06 |
| 07640332478066 | SCARLET® AC-Ti | SpineArt SA | 2024-08-06 |
| 07640332478073 | SCARLET® AC-Ti | SpineArt SA | 2024-08-06 |
| 07640332478080 | SCARLET® AC-Ti | SpineArt SA | 2024-08-06 |
| 07640332478097 | SCARLET® AC-Ti | SpineArt SA | 2024-08-06 |
| 07640332478103 | SCARLET® AC-Ti | SpineArt SA | 2024-08-06 |
| 07640332478110 | SCARLET® AC-Ti | SpineArt SA | 2024-08-06 |
| 07640332477946 | SCARLET® AC-Ti | SpineArt SA | 2024-08-05 |
| 07640332478035 | SCARLET® AC-Ti | SpineArt SA | 2024-08-05 |
| 07640332478028 | SCARLET® AC-Ti | SpineArt SA | 2024-08-05 |
| 07640332477977 | SCARLET® AC-Ti | SpineArt SA | 2024-08-05 |
| 07640332477960 | SCARLET® AC-Ti | SpineArt SA | 2024-08-05 |
| 07640332477953 | SCARLET® AC-Ti | SpineArt SA | 2024-08-05 |
| 07640332477939 | SCARLET® AC-Ti | SpineArt SA | 2024-08-05 |
| 07640332477922 | SCARLET® AC-Ti | SpineArt SA | 2024-08-05 |
| 07640332477915 | SCARLET® AC-Ti | SpineArt SA | 2024-08-05 |
| 07640332477908 | SCARLET® AC-Ti | SpineArt SA | 2024-08-05 |
| 07640332477892 | SCARLET® AC-Ti | SpineArt SA | 2024-08-05 |
| 07640332477885 | SCARLET® AC-Ti | SpineArt SA | 2024-08-05 |
| 07640332477878 | SCARLET® AC-Ti | SpineArt SA | 2024-08-05 |
| 07640332477861 | SCARLET® AC-Ti | SpineArt SA | 2024-08-05 |
| 07640185341791 | SCARLET® AC-T Secured Anterior Cervical Cage | SpineArt SA | 2019-03-08 |
| 07640185341777 | SCARLET® AC-T Secured Anterior Cervical Cage | SpineArt SA | 2019-03-08 |
| 07640185341753 | SCARLET® AC-T Secured Anterior Cervical Cage | SpineArt SA | 2019-03-08 |
| 07640185341739 | SCARLET® AC-T Secured Anterior Cervical Cage | SpineArt SA | 2019-03-07 |