FDA.report

510(k) K252774

Device
Uni-C Cervical Cage System
Applicant
ZheJiang Decans Medical Devices Co., Ltd.
510(k) number
K252774
Product code
OVE
Decision
Substantially Equivalent (SESE)
Decision date
2026-04-15
Date received
2025-09-02
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

Related Records

Applicant Contact

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

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code OVE

510(k)DeviceApplicantDecision date
K260660SABER-C SystemElevation Spine2026-04-27
K253213SAGI Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.2026-04-20
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
K250540SABER-C SystemElevation Spine2025-08-08
K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC2025-07-30
K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation2025-06-27
K251117Cervical Spine Truss System (CSTS)4Web Medical2025-04-25
K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.2025-04-10
K243188CYLOX® STSignus Medizintechnik GmbH2025-02-11
K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine2025-02-07
K242517ProAM ACDF SystemPro Surgical, Inc.2024-11-20
K241846E3D™-C Interbody SystemEvolution Spine2024-08-12