Cervical Spine Truss System (CSTS)
FDA 510(k) K251117 · 4Web Medical
510(k) numberK251117
Submission
- Device name
- Cervical Spine Truss System (CSTS)
- Applicant
- 4Web Medical
Frisco, TX, US - Received
- April 11, 2025
- Decision date
- April 25, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OVE – Intervertebral Fusion Device With Integrated Fixation, Cervical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3080
- Specialty
- Orthopedic
- Implant
- Yes
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.
Other 510(k)s with product code OVE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261882 | Pisces-SC Standalone Cervical Interbody SystemOVE · Traditional | Osseus Fusions Systems, LLC | 08/21/2026SE |
| K261451 | ZSAlign Cervical Interbody SystemOVE · Traditional | ZSFab, Inc. | 07/31/2026SE |
| K262094 | E3D-C Interbody SystemOVE · Special | Evolution Spine | 07/22/2026SE |
| K261279 | DeltaNEC Interbody SystemOVE · Traditional | Nexus Spine | 06/22/2026SE |
| K252982 | CONDUIT ZERO-P VA Secured Spacer SystemOVE · Traditional | Avalign Technologies, Inc. | 06/18/2026SE |
| K260036 | NeckTune 3D SA Cervical CageOVE · Traditional | Medyssey Co, Ltd. | 06/15/2026SE |
| K260660 | SABER-C SystemOVE · Traditional | Elevation Spine | 04/27/2026SE |
| K253213 | SAGI Cervical Cage SystemOVE · Traditional | ZheJiang Decans Medical Devices Co., Ltd. | 04/20/2026SE |
| K252774 | Uni-C Cervical Cage SystemOVE · Traditional | ZheJiang Decans Medical Devices Co., Ltd. | 04/15/2026SE |
| K260038 | E3D-C Interbody SystemOVE · Special | Evolution Spine | 02/04/2026SE |
More from Evolution Spine
| 510(k) | Device | Decision |
|---|---|---|
| K252834 | Sacroiliac Joint Truss System (SJTS)OUR · Traditional | 01/28/2026SE |
| K253200 | Cervical Spine Truss System - Stand Alone (CSTS-SA)OVE · Traditional | 12/11/2025SE |
| K240388 | Osteotomy Truss System (OTS)HRS · Traditional | 11/01/2024SE |
| K233966 | Anterior Spine Truss System-Stand Alone (ASTS-SA)OVD · Traditional | 04/22/2024SE |
| K230088 | Ankle Truss System (ATS)SAI · Traditional | 03/21/2024SE |
| K231739 | Cervical Spine Truss System (CSTS)OVE · Traditional | 09/25/2023SE |
| K223362 | Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion DeviceOVE · Traditional | 02/02/2023SE |
| K221266 | Cervical Spine Truss System (CSTS) Interbody Fusion DeviceODP · Traditional | 01/05/2023SE |
| K221283 | Hammertoe Truss System (HTS)HTY · Traditional | 09/06/2022SE |
| K220463 | Osteotomy Truss System (OTS)HRS · Traditional | 05/18/2022SE |
Questions and answers
When was Cervical Spine Truss System (CSTS) cleared by the FDA?
Cervical Spine Truss System (CSTS) (K251117) received a 510(k) decision of Substantially Equivalent on April 25, 2025, 14 days after the submission was received.
What is the product code of K251117?
The FDA product code is OVE – Intervertebral Fusion Device With Integrated Fixation, Cervical, a Class II (moderate risk) device regulated under 21 CFR 888.3080.