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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 Bone Graft, Lumbar
510(k) Number K170890
Device Name TELIX K Interbody System
Applicant
Biedermann Motech GmbH & Co. KG
Bertha-Von-Suttner-Straße 23
Villingen-Schwenningen,  DE 78054
Applicant Contact Gerd Federle
Correspondent
Biedermann Motech GmbH & Co. KG
Bertha-Von-Suttner-Str. 23
Villingen-Schwenningen,  DE 78054
Correspondent Contact Gerd Federle
Regulation Number888.3080
Classification Product Code
MAX  
Date Received03/27/2017
Decision Date 06/02/2017
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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