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FDA 510(k)

CYLOX® ST

K-Number: K243188 · 2025-02-11

ApplicantSignus Medizintechnik GmbH
Decision Date2025-02-11
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CYLOX® ST is the device name listed in this FDA 510(k) record. The listed applicant is Signus Medizintechnik GmbH. It received FDA 510(k) clearance on 2025-02-11 under 510(k) number K243188. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CYLOX® ST?

CYLOX® ST is a medical device that received FDA 510(k) clearance on 2025-02-11. The listed applicant is Signus Medizintechnik GmbH. The 510(k) number is K243188.

When did CYLOX® ST receive FDA 510(k) clearance?

CYLOX® ST received FDA 510(k) clearance on 2025-02-11, under 510(k) number K243188.

Who is the listed applicant for CYLOX® ST?

The FDA 510(k) record lists Signus Medizintechnik GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CYLOX® ST?

The FDA product code for CYLOX® ST is OVE.

Other records listing Signus Medizintechnik GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241438Signus Tetris™ St; Signus Tetris™ R StK220658COSY Cervicothoracic Occipital Rod-Screw SystemK212755SIGNUS SACRONAIL® Transsacral Stabilization SystemK203327VERTACONNECT TLIF CageK151704Diplomat® Spinal System

Related Devices (Code: OVE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261451ZSAlign Cervical Interbody SystemZSFab, Inc.K262094E3D™-C Interbody SystemEvolution SpineK261279DeltaNEC Interbody SystemNexus SpineK252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.K260660SABER-C SystemElevation Spine

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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