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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intervertebral Fusion Device With Integrated Fixation, Cervical
510(k) Number K243188
Device Name CYLOX® ST
Applicant
Signus Medizintechnik GmbH
Industriestrasse 2
Alzenau,  DE D-63755
Applicant Contact Antje Schmidt
Correspondent
Jalex Medical, LLC
27865 Clemens Rd.
Suite 3
Westlake,  OH  44145
Correspondent Contact Emily Szabo
Regulation Number888.3080
Classification Product Code
OVE  
Subsequent Product Codes
MAX   ODP  
Date Received09/30/2024
Decision Date 02/11/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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