FDA 510(k)

CYLOX® ST

K-Number: K243188 · 2025-02-11

Decision Date2025-02-11

Product CodeOVE

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

CYLOX® ST is a medical device manufactured by Signus Medizintechnik GmbH. It received FDA 510(k) clearance on 2025-02-11 under approval 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. It is manufactured by Signus Medizintechnik GmbH. The 510(k) number is K243188.

When was CYLOX® ST approved by the FDA?

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

What company makes CYLOX® ST?

CYLOX® ST is manufactured by Signus Medizintechnik GmbH.

What is the FDA product code for CYLOX® ST?

The FDA product code for CYLOX® ST is OVE.

Other Devices by Signus Medizintechnik GmbH

K151704Diplomat® Spinal System K220658COSY Cervicothoracic Occipital Rod-Screw System K212755SIGNUS SACRONAIL® Transsacral Stabilization System K241438Signus Tetris St; Signus Tetris R St

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Official Source

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