Cylox® ST
FDA 510(k) K243188 · Signus Medizintechnik GmbH
510(k) numberK243188
Submission
- Device name
- Cylox® ST
- Applicant
- Signus Medizintechnik GmbH
Alzenau, DE - Received
- September 30, 2024
- Decision date
- February 11, 2025
- 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 |
| K253213 | SAGI Cervical Cage SystemOVE · Traditional | ZheJiang Decans Medical Devices Co., Ltd. | 04/20/2026SE |
| 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 |
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| K212755 | SIGNUS SACRONAIL® Transsacral Stabilization SystemHWC · Traditional | 03/10/2022SE |
| K203327 | VERTACONNECT TLIF CageMAX · Traditional | 01/25/2021SE |
| K151704 | Diplomat® Spinal SystemNKB · Traditional | 04/13/2016SE |
| K141405 | Mobis II ST Spinal ImplantMAX · Traditional | 09/16/2014SE |
| K123758 | Tasmin RMQP · Traditional | 01/14/2014SE |
| K131372 | Mobis IIMAX · Traditional | 07/02/2013SE |
| K122317 | Tetris IIMAX · Special | 08/29/2012SE |
| K111792 | Mobis, Moval, Semial, Tetrismodel PEEK and Titanium, Kimba Model Standard and MiniMAX · Traditional | 03/05/2012SE |
Questions and answers
When was Cylox® ST cleared by the FDA?
Cylox® ST (K243188) received a 510(k) decision of Substantially Equivalent on February 11, 2025, 134 days after the submission was received.
What is the product code of K243188?
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.