FDA.reportPublic FDA data

510(k) K242483

Device
Genesys Spine AIS-C II Cervical Interbody Fusion System
Applicant
Genesys Spine
510(k) number
K242483
Product code
OVE
Decision
Substantially Equivalent (SESE)
Decision date
2025-02-07
Date received
2024-08-21
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
No

Applicant Contact#

Contact
Derek Southard
Address
1250 S. Capital Of Texas Hwy. Bldg. 3, Suite 600 Austin TX US 78746 78746

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
K260660SABER-C SystemElevation Spine2026-04-27
K253213SAGI Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.2026-04-20
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
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
K242517ProAM ACDF SystemPro Surgical, Inc.2024-11-20
K241846E3D™-C Interbody SystemEvolution Spine2024-08-12