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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spinal Vertebral Body Replacement Device - Cervical
510(k) Number K173893
Device Name Trabis
Applicant
Coligne AG
Utoquai 43
Zurich,  CH CH 8008
Applicant Contact Robert Lange
Correspondent
The OrthoMedix Group, Inc.
1001 Oakwood Blvd.
Round Rock,  TX  78681
Correspondent Contact J. D. Webb
Regulation Number888.3060
Classification Product Code
PLR  
Date Received12/21/2017
Decision Date 09/06/2018
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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