DeltaNEC Interbody System
FDA 510(k) K261279 · Nexus Spine
510(k) numberK261279
Submission
- Device name
- DeltaNEC Interbody System
- Applicant
- Nexus Spine
Salt Lake City, UT, US - Received
- April 17, 2026
- Decision date
- June 22, 2026
- 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 |
| 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 |
| K253876 | HEDRON Cervical Spacers (HEDRON C-MIS Spacer)OVE · Special | Globus Medical, Inc. | 12/22/2025SE |
More from Globus Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K253331 | PressON Spinal Fixation SystemNKB · Special | 10/14/2025SE |
| K243934 | Stable-L Lumbar Interbody SystemOVD · Traditional | 04/30/2025SE |
| K241467 | Stable-C Interbody SystemOVE · Traditional | 07/17/2024SE |
| 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 DeltaNEC Interbody System cleared by the FDA?
DeltaNEC Interbody System (K261279) received a 510(k) decision of Substantially Equivalent on June 22, 2026, 66 days after the submission was received.
What is the product code of K261279?
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.