SAGI Cervical Cage System
FDA 510(k) K253213 · ZheJiang Decans Medical Devices Co., Ltd.
510(k) numberK253213
Submission
- Device name
- SAGI Cervical Cage System
- Applicant
- ZheJiang Decans Medical Devices Co., Ltd.
Jiaxing, CN - Received
- September 29, 2025
- Decision date
- April 20, 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 |
| 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 |
|---|---|---|
| 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 |
| K252774 | Uni-C Cervical Cage SystemOVE · Traditional | 04/15/2026SE |
| 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 SAGI Cervical Cage System cleared by the FDA?
SAGI Cervical Cage System (K253213) received a 510(k) decision of Substantially Equivalent on April 20, 2026, 203 days after the submission was received.
What is the product code of K253213?
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.