Stable-C Interbody System
FDA 510(k) K241467 · Nexus Spine, LLC
510(k) numberK241467
Submission
- Device name
- Stable-C Interbody System
- Applicant
- Nexus Spine, LLC
Salt Lake City, UT, US - Received
- May 23, 2024
- Decision date
- July 17, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
|---|---|---|
| K261279 | DeltaNEC Interbody SystemOVE · Traditional | 06/22/2026SE |
| K253331 | PressON Spinal Fixation SystemNKB · Special | 10/14/2025SE |
| K243934 | Stable-L Lumbar Interbody SystemOVD · Traditional | 04/30/2025SE |
| K233375 | Tranquil-L Interbody SystemMAX · Special | 03/20/2024SE |
| K240416 | Tranquil-C Interbody SystemODP · Special | 03/12/2024SE |
| K233234 | PressON Spinal Fixation SystemNKB · Special | 10/26/2023SE |
| K231486 | Stable-L Standalone Lumbar Interbody SystemOVD · Traditional | 10/12/2023SE |
| K232530 | Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemOVD · Special | 09/18/2023SE |
| K231763 | Stable-C Interbody SystemOVE · Traditional | 08/21/2023SE |
| K223529 | PressON Spinal Fixation SystemNKB · Traditional | 05/02/2023SE |
Questions and answers
When was Stable-C Interbody System cleared by the FDA?
Stable-C Interbody System (K241467) received a 510(k) decision of Substantially Equivalent on July 17, 2024, 55 days after the submission was received.
What is the product code of K241467?
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.