FDA.reportPublic FDA data

510(k) K243188

Device
CYLOX® ST
Applicant
Signus Medizintechnik GmbH
510(k) number
K243188
Product code
OVE
Decision
Substantially Equivalent (SESE)
Decision date
2025-02-11
Date received
2024-09-30
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
Antje Schmidt
Address
Industriestrasse 2 Alzenau DE D-63755 D-63755

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
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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
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