NeckTune 3D SA Cervical Cage
FDA 510(k) K260036 · Medyssey Co, Ltd.
510(k) numberK260036
Submission
- Device name
- NeckTune 3D SA Cervical Cage
- Applicant
- Medyssey Co, Ltd.
Jecheon-Si, KR - Received
- January 6, 2026
- Decision date
- June 15, 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 |
| 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 |
| 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 |
|---|---|---|
| K242806 | Medyssey Navigation SystemOLO · Traditional | 04/16/2025SE |
| K121670 | Medyssey Cannulated Pedicle ScrewNKB · Traditional | 01/25/2013SE |
| K121320 | C7 Anterior Cervical Intervertebral Fusion CageODP · Traditional | 08/10/2012SE |
| K121246 | Medyssy LT Cage SystemMAX · Special | 06/15/2012SE |
| K110284 | Novel III Spinal Fixation and Adjustable Bridge SystemMNI · Special | 06/08/2011SE |
| K110283 | Zenius Spinal SystemMNI · Special | 05/19/2011SE |
| K110067 | LP CageMAX · Traditional | 04/08/2011SE |
| K103272 | Zenius Spinal SystemMNI · Special | 12/29/2010SE |
| K103147 | Novel III Spinal Fixation and Adjustable Bridge SystemMNI · Special | 12/16/2010SE |
| K093104 | Medyssey Co., Ltd., Zenius Spinal SystemMNI · Traditional | 06/25/2010SE |
Questions and answers
When was NeckTune 3D SA Cervical Cage cleared by the FDA?
NeckTune 3D SA Cervical Cage (K260036) received a 510(k) decision of Substantially Equivalent on June 15, 2026, 160 days after the submission was received.
What is the product code of K260036?
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.