Uni-C Cervical Cage System
FDA 510(k) K252774 · ZheJiang Decans Medical Devices Co., Ltd.
510(k) numberK252774
Submission
- Device name
- Uni-C Cervical Cage System
- Applicant
- ZheJiang Decans Medical Devices Co., Ltd.
Jiaxing City, CN - Received
- September 2, 2025
- Decision date
- April 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 |
| 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 |
| 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 |
|---|---|---|
| K253046 | HERA Interlocking Intramedullary Nailing SystemHSB · Traditional | 06/16/2026SE |
| K253195 | TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsNKG · Traditional | 06/02/2026SE |
| K253130 | Dione PEEK Screw SystemMBI · Traditional | 05/27/2026SE |
| K252930 | AQUA Laminoplasty SystemsNQW · Traditional | 05/27/2026SE |
| K252776 | ARIES Anterior Cervical Plate SystemsKWQ · Traditional | 05/14/2026SE |
| K252542 | LEO Spinal SystemNKB · Traditional | 04/29/2026SE |
| K253213 | SAGI Cervical Cage SystemOVE · Traditional | 04/20/2026SE |
| K243665 | Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor System…MBI · Traditional | 01/31/2025SE |
| K242195 | Gemini Cervical Fusion Cage SystemODP · Traditional | 11/04/2024SE |
| K242267 | Gemini Medical Cage SystemMAX · Traditional | 10/08/2024SE |
Questions and answers
When was Uni-C Cervical Cage System cleared by the FDA?
Uni-C Cervical Cage System (K252774) received a 510(k) decision of Substantially Equivalent on April 15, 2026, 225 days after the submission was received.
What is the product code of K252774?
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.