FDA.reportPublic FDA data

510(k) K253213

Device
SAGI Cervical Cage System
Applicant
ZheJiang Decans Medical Devices Co., Ltd.
510(k) number
K253213
Product code
OVE
Decision
Substantially Equivalent (SESE)
Decision date
2026-04-20
Date received
2025-09-29
Regulation
888.3080
Classification name
Intervertebral Fusion Device With Integrated Fixation, Cervical
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Haifeng Liu
Address
#2836 Xincheng Ave., Gaozhao St. Xiuzhou District Jiaxing CN 314031 314031

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OVE#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K263113ZSAlign Cervical Interbody SystemZSFab, Inc.2026-10-02
K262726NeckTune™ SA Cervical CageMedyssey Co., Ltd.2026-09-29
K263049SABER-C SystemElevation Spine2026-09-23
K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC2026-08-21
K261451ZSAlign Cervical Interbody SystemZSFab, Inc.2026-07-31
K262094E3D™-C Interbody SystemEvolution Spine2026-07-22
K261279DeltaNEC Interbody SystemNexus Spine2026-06-22
K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.2026-06-18
K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.2026-06-15
K260660SABER-C SystemElevation Spine2026-04-27
K252774Uni-C Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.2026-04-15
K260038E3D™-C Interbody SystemEvolution Spine2026-02-04
K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.2025-12-22
K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.2025-12-11
K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis2025-09-25